Abstract of dissertation entitled

The Use of Topical Anesthesia to Reduce Pediatric

IV Cannulation Pain in an Emergency Department

Submitted by

Lai Yat Ming

for the degree of Master of Nursing

at The University of Hong Kong

in August 2012

Intravenous cannulation of pediatric patients is a common procedure in

emergency departments. It is a useful tool to facilitate medical investigations and

drug administration. However, the pain induced by the procedure can lead to

patient distress and bother the nursing and medical procedures afterwards. There

are many kinds of topical anesthesia but no relevant evidence-based guideline for

their use is available for the emergency departments. This dissertation synthesizes

the available evidence in the literature to establish an evidence-based guideline for

the use of topical anesthesia to reduce pain caused by pediatric intravenous

cannulation in an emergency department. The communication, implementation

and evaluation plan are also developed.

A systematic literature review was conducted from 30th August to 2nd September,

2011. A number of electronic databases, including PubMed, CINAHL Plus and

Embase were searched. Thirteen eligible randomized controlled trials were

identified. They were integrated into a table of evidence and were critically

appraised by the SIGN Methodology Checklist. After synthesis of evidence, it is

suggested that needleless anesthesia with apparatus assistance significantly

reduced pain as early as in five minutes. Patients should however be observed for

two hours after the administration of anesthesia for signs of adverse effects.

The implementation potential, in terms of the transferability, feasibility and

cost-benefit ratio, was examined. Among the anesthesia devices, the Jet lidocaine

device has satisfactory transferability, feasibility and cost-benefit ratio. The

evidence is then translated into a practice guideline with the recommendations

scored based on the “SIGN 50: A guideline developer’s handbook”.

A fourteen-month implementation plan,including a communication plan, a pilot

study and an evaluation plan is developed. The communication phase lasts for

three months and the stakeholders including the Chief of Service, Department

Operation Manager, Advanced Practice Nurses, frontline healthcare

professionals and the pharmacy department are identified. The pilot plan lasts for

ten weeks, which includes a two-week training period, a three-week

observational period for baseline measurement, a three-week intervention period

and an eight-week amendment period. The pilot study collects data regarding the

pain level at baseline and identifies unanticipated problems in the guideline.

Amendments would be made accordingly and the revised guideline would be

sent for ethical approval before the implementation phase.

In the evaluation plan, the primary outcome for the innovation is the level of pain.

The secondary outcomes are the admission rate and length of hospital stay. Other

outcomes are the satisfaction of healthcare professionals, utilization rate and cost.

It is expected that the cannulation pain, admission rate and length of hospital stay

would be lower with the application of topical anesthesia.

The Use of Topical Anesthesia to Reduce Pediatric

IV Cannulation Pain in an Emergency Department

by

Lai Yat Ming Bachelor of Nursing (Honours) H.K.U.

A dissertation submitted in partial fulfillment of the requirement for

the degree of Master of Nursing

at The University of Hong Kong.

August 2012

i

Declaration

I declare that this dissertation represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

Signed:___________________________

Mr Lai Yat Ming

ii

Acknowledgements

In the writing process of this dissertation, I would like to thank Dr. Daniel Fong,

an Associate Professor as well as my academic supervisor. He shows great

patience and provides timely and inspiring advice for me for many times.

Moreover, he also criticizes the possible flaws and suggests logical flow to

improve the integrity of the dissertation.

I would also like to express my gratitude to academic and administrative staff of

School of Nursing, The University of Hong Kong. Their professional teaching

attitude and efficient administrative services facilitate my school life in the master

course.

iii

Table of Contents

Declaration ……………………………………………………………………………… i

Acknowledgement …………………………………………………………………………ii

Table of contents …………………………………………………………………………iii

List of appendices …………………………………………………………………………v

CHAPTER 1 – INTRODUCTION

1.1 BACKGROUND …………………………………………………………... 1

1.2 AFFIRMING THE NEED ………………………………………………… 3

1.3 OBJECTIVES AND SIGNIFICANCE …………………………………….. 5

CHAPTER 2 – CRITICAL APPRAISAL

2.1 SEARCH AND APPRAISAL STRATEGIES ………………………………. 7

2.2 RESULTS …………………………………………………………………... 8

2.2.1 Search results ………………………………………………... 8

2.2.2 Study characteristics …………………………………………... 9

2.2.3 Methodological quality assessment…………………………... 10

2.3 SUMMARY AND SYNTHESIS ……………………………………………12

2.3.1 Anesthetic effect ……………………………………………... 12

2.3.2 Initial cannulation success rates……………………………... 14

2.3.3 Safety ……………………………………………………….. 14

2.3.4 Follow up for adverse effects………………………………... 15

2.3.5 Time of onset and anesthesia application…………………... 15

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2.3.6 Use of dressing……………………………………………... 16

2.3.7 Suggestions from synthesis of evidence……………………... 16

CHAPTER 3 – TRANSLATION AND APPLICATION

3.1 IMPLEMENTATION POTENTIAL …………………………………….. 18

3.1.1 Transferability……………………………………………… 18

3.1.2 Feasibility ……………………………………………………..21

3.1.3 Cost-benefit ratio of the innovation………………………….. 23

3.2 EVIDENCE-BASED PRACTICE GUIDELINE ………………………... 27

CHAPTER 4 – IMPLEMENTATION PLAN

4.1 COMMUNICATION PLAN………………………………………………. 29

4.1.1 Identification of stakeholders ………………………………. 29

4.1.2 Strategies of change: initiation, guiding and sustaining……. 30

4.2 PILOT PLAN……………………………………………………………... 33

4.2.1 Design ……………………………………………………… 33

4.2.2 Subjects …………………………………………………….. 34

4.2.3 Preparation…………………………………………………... 34

4.2.4 Measurement ………………………………………………. 35

4.2.5 Review of guideline ………………………………………... 36

4.3 EVALUATION PLAN ……………………………………………………. 36

4.3.1 Outcomes and measurements ………………………………. 37

4.3.2 Nature and number of clients to be involved ……………… 39

4.3.3 Timing and frequency of taking measurements …………… 40

4.3.4 Data analysis ………………………………………………. 40

4.3.5 Basis for adopting innovation ……………………………... 41

APPENDICES ………………………………………………………………… 43

REFERENCES ………………………………………………………………... 109

v

List of Appendices

Appendix 1 - Searching Strategies for Existing Guidelines/ Protocols ………... 43

Appendix 2 - Searching Strategies for Systematic Reviews …………………... 43

Appendix 3 - Searching Strategies for Primary Studies ………………………... 44

Appendix 4 - Table of Evidence ………………………………………………... 46

Appendix 5 - Methodological Quality Appraisal ……………………………... 57

Appendix 6 - NTWC Pain Assessment Tool …………………………………... 83

Appendix 7 - Material cost of J-Tip Injector innovation (per year) …………... 84

Appendix 8 - Material cost of Sonoprep innovation (per year) ………………... 84

Appendix 9 - Material cost of Er:YAG Laser innovation (per year) …………... 85

Appendix 10 - Staff Cost (Setup Cost) ………………………………………... 86

Appendix 11 - Estimated Cost of Innovation ………………………………… 86

Appendix 12 - Cost of Current Practice ………………………………………... 86

Appendix 13 - Evidence-based Guideline …………………………………….... 87

Appendix 14 - Gantt Chart of Implementation Plan ………………………….103

Appendix 15 - Opinion for Pilot Test ………………………………………... 104

Appendix 16 - Pediatric IV Cannulation Record ……………………………... 105

Appendix 17 - Evaluation Table ……………………………………………... 107

Appendix 18 - Satisfactory Survey for Healthcare Providers ………………... 108

1

CHAPTER 1: INTRODUCTION

1.1 BACKGROUND

Intravenous cannulation is the placement of intravenous catheter through skin

puncture, for the purpose of drug administration, rehydration or blood transfusion.

It is one of the most common invasive procedures in emergency departments

(Kim, Kini, Troshynski & Hennes, 1999; Klein, Shugerman, Leigh-Taylor,

Schneider, Portscheller & Koepsell, 1995).In2005, there were more than 27

million attempts of venipuncture in the emergency departments in the United

States (Nawar, Niska & Xu, 2007). In particular, it is commonplace for pediatric

patients (Bulechek, McCloskey, Titler & Denehey, 1994; Doniger, Ishimine, Fox

& Kanegaye, 2009).

Needle insertion may cause significant pain (Costello, Ramundo, Christopher &

Powell, 2006; Singer & Richman, 1999). It is one of the main sources of pain in

the emergency departments (Auerbach, Tunik & Mojica, 2009). Pain can cause

fear and anxiety in children (Jacobson et al., 2001) and leads to needle-phobia.

This makes cannulation the most unpleasant experience for the pediatric patients

and increases their pain sensation in the needle-related procedure afterwards

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(Cummings, Reid, Finley, McGrath, & Ritchie, 1996; Singer & Richman, 1999).

The distress does not only affect the children, but also their parents, and even

healthcare providers (Dollfus et al., 1995; Kim et al., 1999; Klein et al., 1995;

Shavit, Hadash, Knaani-Levinz, Shachor-Meyouhas & Kassis, 2009). The distress

can cause acute and long-term, physiological and psychological influences (Acute

Pain Management Guideline Panel,1992; Schechter, Berde & Yaster, 1993;

Terndrup ,1996; Walco, Cassidy & Schechter, 1994; Weisman, Bernstein &

Schechter,1998; von Baeyer, Marche, Rocha & Salmon, 2004; Zeltzer et al.,1990;

Zempsky & Schechter, 2003).Therefore, perceived pain management is an

important issue in the healthcare settings, especially in the pediatric emergency

departments.

The American Academy of Pediatrics Task Force on Pain in Infants, Children, and

Adolescents (2001) stated that local anesthetics should be used in intravenous

cannulation to minimize distress. Local anesthesia like lidocaine infiltration has

been used during needle insertion. However, although it provides significant

anesthetic and analgesic effects, the infiltration itself causes pain (Armstrong,

Young & Mckeown, 1990; Langham & Harrison, 1992; Selby & Bowles, 1995).

Nevertheless, needleless topical anesthesia can avoid injection pain. It is effective

3

in reducing pain in painful procedures (Barnett, 2009). As a result, topical

anesthesia is perceived as the standard care before pediatric venipuncture (Arendts,

Stevens & Fry, 2008).

1.2 AFFIRMING THE NEED

Pediatric intravenous cannulation is the most common procedure in the

emergency department, other than the pediatric ward, in an acute hospital in Hong

Kong. About 10% of the pediatric patients in the emergency departments are

critically ill and need intravenous therapy. However, there is no evidence-based

guideline in the local setting to inform proper practice. Indeed, no evidence-based

guideline was found in the National Guideline Clearinghouse, CMA InfoBase,

Health Services/Technology, Assessment Text, Guidelines Advisory Committee,

Scottish Intercollegiate Guideline Network (SIGN), National Institute for Clinical

Excellence, New Zealand Guidelines Group and Guidelines International Network

on 30th August 2011.

The current practice in the local setting only offers catheterization without any

anesthesia. It is because topical anesthesia for intravenous cannulation is not

encouraged in the department as it takes long time for onset, generally thirty

4

minutes to an hour. Also, it is considered time-consuming by some healthcare

professionals but the distress caused may be underestimated. As a result, the child

may have to be restrained physically in order to perform the cannulation after

gaining parental consent. This cannot relieve the fear and pain of the children and

the distress of the parents. Forced venipuncture for uncooperative children may

cause failure of intravenous cannulation. It can also cause extra pain and damage

to the peripheral tissues. It can also lead to needle-stick injury to the healthcare

professionals who perform this procedure. Moreover, the frustration of parents can

turn into serious consequences. Their unstable emotions may result in complaint

cases or even workplace violence. As one of the busiest emergency departments in

Hong Kong, manpower is tight and workload is heavy. It can be time-consuming

to deal with difficult cannulation and the distressed parents. It is not bearable to

use our precious manpower and time to calm the parents down. Workplace

violence also poses threat to our staff and worsens our productivity immediately

or permanently.

On the other hand, some healthcare professionals may try to avoid the above

conditions by prescribing drugs by other routes like the oral route, or even admit

the child, leaving the task to the ward staff. This practice may cause delayed

5

treatment or under-treatment, which puts the patient at risk. Pediatric beds should

be saved for patients who are really in need but not because of such reason.

Although topical anesthesia may be helpful in intravenous cannulation, studies for

the usage of topical anesthesia in the emergency settings still yield mixed results.

Therefore, it is necessary to evaluate the performance of topical anesthesia for

pediatric patients before intravenous cannulation. Thus, the research question

would be: What is the effectiveness and safety of using topical anesthesia (EMLA,

ELA-Max and lidocaine gel, ethylchloride spray, lidocaine/tetracaine patch and jet

lidocaine) for intravenous cannulation of pediatric patients in the emergency

settings?

We hypothesize that topical anesthesia causes less pain than local anesthesia in

administration and that topical anesthesia is as effective as local anesthesia. In the

coming review, the safety and efficacy in terms of the pain level, anxiety level and

the initial cannulation success rates of using different topical anesthesia will be

discussed.

1.3 OBJECTIVES AND SIGNIFICANCE

6

The objectives of this dissertation are:

i. To evaluate current evidence for topical anesthesia usage in pediatric

intravenous cannulation in the emergency settings;

ii. To develop an evidence-based protocol on topical anesthesia for pediatric

intravenous cannulation;

iii. To assess the transferability and feasibility of implementing the topical

anesthesia protocol in the emergency settings in Hong Kong;

iv. To develop implementation strategies and an evaluation plan for topical

anesthesia for the pediatric intravenous cannulation protocol in the local

emergency settings.

Adequate pain control has several significant benefits. First, pain control before

intravenous cannulation can reduce distress in children and their parents. Second,

it can help to provide early investigation, diagnosis and treatment. Third, it can

also lower the pediatric admission rates and admission costs. Fourth, it would

benefit the pediatric patients, their parents and the hospital as a whole.

7

CHAPTER 2: CRITICAL APPRAISAL

2.1 SEARCH AND APPRAISAL STRATEGIES

Studies were included if:

i. the target population were children under the age of 18 years;

ii. it was conducted in the emergency settings; and

iii. the intravenous cannulation was done with topical anesthesia.

Studies were be excluded if:

i. only lidocaine infiltration was received; or

ii. it was not a randomized controlled trial.

The Cochrane library was used for searching systematic reviews while PubMed,

CINAHL Plus and Embase were used for searching primary studies. The

keywords used were (Topical anesthesi* OR Local anesthesi*) AND (Vein

catheterization OR Venous catheterization OR Vascular access OR Venous access

OR Venipuncture OR Venepuncture OR cannulation OR needle insertion) AND

(Emergency department OR emergency service OR emergency setting OR ED).

The search was limited to randomized controlled trials and pediatric patients aged

zero ro eighteen. Titles and abstracts were screened to eliminate irrelevant articles.

8

Duplicated articles were excluded. The references lists of the eligible studies were

also screened to identify other potential studies.

Critical appraisal of all eligible studies was done according to the SIGN

Methodology Checklist for randomized controlled trials (SIGN, 2004). The

question statement, randomization, concealment method, blinding, similarity

between groups, validity and reliability, drop-out rate, intention to treat analysis

and study site comparability were considered in the quality assessment. A “++”

would be scored if all or most of the criteria are fulfilled, meaning that the

conclusion of study would be very unlikely altered by bias. A “+” would be scored

if some of the criteria are fulfilled, meaning that the conclusion of study would be

unlikely altered. A “-“ would be scored if few or none of the criteria are fulfilled

and the conclusion would be likely altered.

2.2 RESULTS

2.2.1 Search results

The electronic database search was done between 30th August 2011 and 2nd

September 2011. No guideline was found with the keywords (Appendix 1). The

Cochrane library was also used to search for existing systematic reviews but no

9

result was found (Appendix 2). Appendix 3 summarizes the search results using

the search strategy and screening method. After keyword search using Pubmed,

CINAHL Plus and Embase, a total of eighty-seven articles were found. Eighteen

articles were left after the titles and abstracts were screened. After full text

screening and elimination of duplications, twelve articles were selected. Although

the full text of one of the study (Mann, Taylor & Smit, 2007) could not be

retrieved, the abstract already contained adequate information for the systematic

review. One additional relevant article was found after scanning the reference lists

of the twelve studies. Finally, thirteen articles were included in the systematic

review (Arendts et al., 2008; Auerbach et al., 2009; Costello et al., 2006; Kim et

al., 1999; Luhmann, Hurt, Shootman & Kennedy, 2004; Mann et al., 2007;

Newbury & Herd, 2009; Ramsook, Kozinetz,& Moro-Sutherland, 2001; Shavit et

al., 2009; Singer, Taira, Chisena, Gupta & Chipley, 2008; Singer, Weeks, & Regev,

2006; Skarbek-Borowska, Becker, Lovgren, Bates,& Minugh, 2006; Spanos,

Booth, Koenig, Sikes, Gracely& Kim, 2008).

2.2.2 Study characteristics

Demographic characteristics, number of subjects, intervention and comparison

received, length of follow up, outcome measures and effect size are summarized

10

in the table of evidence (Appendix 4). All studies are randomized controlled trials.

Twelve out of thirteen articles only included children as the target group. Only

one study also included adults (Singer et al., 2006). However, since the data from

children were independently analyzed, this study was not excluded. All studies

included needleless topical anesthesia as the intervention, the control or both.

Only one study included subcutaneous lidocaine injection as the intervention

(Luhmann et al.,2004). The duration of follow-up was one week immediately after

the completion of the cannulation procedure. Primary outcome measures in eleven

out of thirteen articles were pain in cannulation, while two of the studies used

initial cannulation success rate as the primary outcome (Auerbach et al., 2009;

Newbury & Herd, 2009). Only the study of Newbury et al. (2009) included the

rated pain score as the secondary outcome. Eight out of thirteen studies recorded

initial successful cannulation rates, while eight out of thirteen studies recorded the

number of adverse events.

2.2.3 Methodological quality assessment

After completing the SIGN checklist (Appendix 5), four articles scored 1++

(Luhmann et al., 2004; Newbury & Herd, 2009; Skarbek-Borowska et al., 2006;

Spanos et al., 2008); seven articles scored 1+ (Arendts et al., 2008; Auerbach et al.,

11

2009; Costello et al., 2006; Ramsook et al., 2001; Shavit et al., 2009; Singer et al.,

2008; Singer et al., 2006) and two articles scored 1- (Kim et al., 1999; Mann et al.,

2007). Research questions were clearly stated in all studies. All of the studies

stated that randomization was applied, but two studies did not report the

randomization methods (Costello et al., 2006; Mann et al., 2007). Most of the

studies described the concealment method, while two studies failed to provide the

corresponding detailed information (Kim et al., 1999; Mann et al., 2007). Nine

studies clearly stated the double-blind method. On the other hand, two studies did

not provide enough information on the blinding method used (Kim et al., 1999;

Mann et al., 2007); and two studies were only single-blinded (Newbury & Herd,

2009; Ramsook et al., 2001). Six out of thirteen studies provided inadequate

demographic data (Costello et al., 2006; Kim et al., 1999; Luhmann et al., 2004;

Mann et al., 2007; Newbury & Herd, 2009; Singer et al., 2006), while two studies

reported significant differences in the prior experience of cannulation and race

(Auerbach et al., 2009; Spanos et al., 2008). In the twelve studies, all subjects

were treated equally to minimize the effect of factors other than the intervention.

However, Mann et al. (2007) did not provide such information in their study. Valid

and reliable scales were used to measure the main findings in all reviewed studies.

All studies reported low drop-out rates (below 14%) while Mann et al. (2007) did

12

not provide such information. All studies, except that of Mann et al. (2007), stated

or implied that the subjects were analyzed by their original allocation. All studies,

except that of Mann et al. (2007), were single-center. Four studies had relatively

small sample size, ranging from 40 to 61, which may not have sufficient power to

detect a discernible effect (Kim et al., 1999; Shavit et al., 2009; Singer et al., 2008;

Singer et al., 2006).

2.3 SUMMARY AND SYNTHESIS

2.3.1 Anesthetic effect

Compared to traditional lidocaine infiltration, one study found that the ELA-Max

cream application had no significant difference in pain score (p=0.19) and anxiety

(p=0.18) (Luhmann et al., 2004). Six studies showed that needleless anesthesia

including ELA-Max (LMX-4), jet lidocaine and lidocaine-based patch can

provide anesthetic effect in pediatric intravenous cannulation in the emergency

settings (Auerbach et al., 2009; Kim et al., 1999; Singer et al.,2008, Singer et

al.,2006;Skarbek-Borowska et al., 2006; Spanos et al., 2008). The Visual Analog

Scale ranged from 0.8 – 3.5mm in the studies (Auerbach et al., 2009; Kim et al.,

1999; Singer et al.,2008, Singer et al.,2006; Skarbek-Borowska et al., 2006;

Spanos et al., 2008).

13

Nevertheless, it was noted that two studies investigating the effect of jet lidocaine

anesthesia found different results. Auerbach et al. (2009) showed that there was

significant difference in jet injections and non-treatment; but no significant

difference was found between jet lidocaine and jet placebo. It may be explained

by the placebo effect. However, jet lidocaine was found to be more effective

compared with the ELA-Max cream in the study of Spanos et al.(2008). The

difference between the studies may be explained by the application to cannulation

time. In the study of Auerbach et al. (2009), the application to cannulation time

was recorded to be less than one minute. Given that the standard lidocaine

infiltration needs five minutes to take effect, it may not be reasonable to have

cannulation in less than one minute after jet lidocaine . On the other hand, the

application to cannulation time used in the study of Spanos et al. (2008) was five

minutes.

In contrast, two studies concluded that ethylchloride spray could not provide

anesthetic effect in pediatric intravenous cannulation (Costello et al.,2006;

Ramsook et al.,2001). Four studies found that the EMLA cream, lidocaine-based

disinfectant, nitrous oxide and amethocaine provide similar anesthesia effect

14

(Arendts et al., 2008; Mann et al., 2007; Newbury & Herd,2009; Shavit et al.,

2009). Unfortunately, no controls or placebo was included for comparison.

Therefore, the actual effect of the individual anesthesia was inconclusive.

2.3.2 Initial cannulation success rates

Among the eight studies that investigated the initial cannulation success rates,only

one study concluded that there was significant difference between the

laser-assisted ELA-Max application and the sham laser (13(87%) vs 8(53%),

p=0.006) (Singer et al., 2006). However, the sample size was too small that the

result may not be generalized. Other studies did not state if there was significant

difference in success rates.

2.3.3 Safety

The use of EMLA, amethocaine, nitrous oxide, LidoDin, topical patch, ultrasound

device and iontophoresis unit may lead to adverse events, including erythema and

edema. As reported in the studies, the incidence rates of the adverse events ranged

from 2.2% to 47.4% (Arendts et al., 2008; Kim et al., 1999; Mann et al., 2007;

Newbury & Herd, 2009; Shavit et al., 2009; Singer et al., 2008;

Skarbek-Borowska et al., 2006).

15

2.3.4 Follow up for adverse effects

Nine studies agreed that follow-up was needed for adverse effects (Arendts et al.,

2008; Auerbach et al., 2009; Costello et al., 2006; Kim et al., 1999; Mann et al.,

2007; Newbury & Herd, 2009; Shavit et al., 2009; Singer et al., 2008; Singer et al.,

2006; Skarbek-Borowska et al., 2006). The follow-up period was ranged between

immediate to one week after anesthesia (Kim et al., 1999; Singer et al., 2006;

Skarbek-Borowska et al., 2006).

2.3.5 Time of onset and anesthesia application

All studies allowed enough time for anesthesia onset. Anesthesia cream or patch

needs thirty to ninety minutes to take effect, while ELA-Max cream or lidocaine

can reduce pain in less than sixty seconds to twelve minutes with the assistance of

device (Auerbach et al., 2009; Kim et al., 1999; Singer et al., 2006;

Skarbek-Borowska et al., 2006; Spanos et al., 2008). Newbury & Herd (2009) and

Singer et al. (2008) suggested that patients should be screened at triage, and the

potential cases for intravenous cannulation should be identified and provided with

topical anesthesia that has long onset time.

16

2.3.6 Use of dressing

Dressing was used in six studies to cover the anesthetic cream site (Arendts et al.,

2008; Luhmann et al., 2004; Shavit et al., 2009; Singer et al., 2006;

Skarbek-Borowska et al., 2006; Spanos et al., 2008). Occlusive dressing was used

in three studies (Arendts et al., 2008; Luhmann et al., 2004; Spanos et al., 2008).

2.3.7 Suggestions from synthesis of evidence

All reliable studies, which scored 1+ or 1++, suggested topical anesthesia,

including ELA-Max, jet lidocaine and lidocaine-based patch, is considered as

effective for pediatric intravenous cannulation pain reduction.

With device assistance, anesthesia can provide adequate effect in five minutes.

Although the onset time of anesthesia in the study of Auerbach et al. (2009) was

less than one minute, it failed to prove its significant difference with the placebo.

On the other hand, Kim failed to provide adequate information in concealment

method and only 10% of eligible participants were able to be captured, that article

of iontophresis is considered as biased (1-).

Most of the studies did not mention the adequate time for reassessment. On the

17

other hand, for those with follow up time stated, adverse events usually occur

immediate after anesthesia application. Hence, follow up time for adverse event

should be up to two hours after anesthesia.

Therefore, the target innovation should be focused at topical anesthesia, including

ELA-Max, jet lidocaine and lidocaine-based patch, with device assistance while

the age of target population would be ranged from five to eighteen as most of the

reliable studies do. Five minutes should be given for the onset of anesthesia.

Reassessment time for adverse events should be up to two hours after anesthesia

application.

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CHAPTER 3:

TRANSLATION AND APPLICATION

3.1 IMPLEMENTATION POTENTIAL

From the analysis in Chapter 2, it is suggested that needleless topical anesthesia

with device assistance is effective for pediatric intravenous cannulation pain

reduction in the emergency setting. It can also provide much rapid onset of

anesthetic effect compared to applying topical anesthetic cream alone. However,

the implementation potential should be explored in order to examine if it is

possible to carry out the innovation in the local setting. According to Polit & Beck

(2004), transferability of the findings, feasibility and cost/benefit ratio should be

included in the implementation potential assessment.

3.1.1 Transferability

The innovation would be implemented at the accident and emergency (A&E)

department of an acute hospital in Hong Kong. Clients in the target setting vary

from infants to the elderly. However, the target population of the innovation

would only be children aged five to eighteen years who need venipuncture. They

would receive needleless topical anesthesia with device assistance prior to

19

venipuncture or cannulation.

It is found that the audience and setting of the proposed setting are similar to those

considered in the studies reviewed in Chapter 2. Although, some of the reviewed

studies were carried out in pediatric emergency departments, there are only

general emergency departments in Hong Kong. However, the age range of the

pediatric clients in our local setting and the reviewed studies is similar, in that

both are children aged five to eighteen years. On the other hand, the settings of the

reviewed studies are similar to the proposed one as they are all conducted in acute

hospitals.

The philosophy of care of the proposed innovation is coherent to that in the target

setting and the organization at large. Pain is the fifth vital sign and should be

managed properly. Inadequate pain management may interrupt nursing and

medical procedures. Therefore, the innovation aims to provide fast and adequate

anesthesia to reduce pain and distress in venipuncture. Moreover, the target setting

is under the New Territories West Cluster (NTWC) of the Hospital Authority,

which is the largest organization of healthcare in Hong Kong. The cluster also

emphasizes pain management and has established policies and assessment tools

20

for pain assessment and management. According to the NTWC Policy on Pain

Management, poor pain management can cause significant impact on patients’

hospital experience and may increase healthcare cost (Hospital Authority, 2010b).

Also, patients should have the right to have proper pain assessment and

management.

According to the Accident & Emergency Information System of Hospital

Authority, the target setting had 221,409 attendances during 1/4/2010-31/3/2011.

Of which, 31,307 cases (14.1%) were children and 5% of them needed

venipuncture for various reasons. Therefore, it is estimated that about 1,565

pediatric patients would be benefited from the innovation each year, and at least

150 pediatric admissions would be reduced per year.

The proposed schedule of innovation would be about fourteen months. In the

preparation phase, the guideline and implementation plan would be developed in

five weeks. A few months would be spared for the approval of the innovation.

Purchase and shipping of apparatus via medical equipment companies may need

two weeks. Staff training would need four weeks. Pilot study and pilot evaluation

would take place in eight weeks. The implementation phase would last for six

21

months. The evaluation phase, including data collection, analysis and evaluation

would spend another two weeks. Compared to the potential benefits which will be

discussed in Section 3.3, this fourteen-month innovation plan is worth launching.

Details of the implementation and evaluation plan are discussed in Chapter 4.

3.1.2 Feasibility

It is suggested that nurses’ autonomy is important to ensure the feasibility of the

innovation (Polit & Beck, 2004). A&E nurses in the target setting have been

educated about pain assessment and topical anesthesia administration. Besides,

they are able to administer topical anesthesia without doctor’s prescription during

the administration of invasive procedures. Lidocaine gel can be used in Foley

catheter insertion and buffered lidocaine can be injected before suturing.

Although providing anesthesia is a common practice in our A&E department, the

innovation may encourage doctors to prescribe more venipuncture-related

procedures. As a result, doctors and nurses may have more venipuncture-related

tasks with each taking eight minutes to complete. Hence, there may be more

cannulated pediatric patients waiting for reassessment in the observation room.

Nevertheless, time can be saved as the clinical symptoms can be relieved faster.

22

Also, the diagnosis can be made earlier as the investigation results can be obtained

earlier.

Both the Hospital Authority and the target department support and encourage

evidence-based practice. The Hospital Authority has developed e-Knowledge

Gateway (eKG), a system that can provide updated evidence-based knowledge.

The Hospital Authority also encourages utilization of evidence (Solomon,2007).

Moreover, the Chief of Service (COS) and the Department Operation Manager

(DOM) of the target A&E department strongly encourage evidence-based

innovations. It is quite often that research projects are launched and published in

peer-reviewed journals. Also, they promote evidence-based innovation in staff by

embedding research utilization during staff training and regard it as one of the

staff responsibilities. These have helped to develop an atmosphere in the A&E

department in that doctors and nurses would explore new knowledge by

conducting research and transfer the new findings into practice. Moreover, our

COS welcomes suggestions that can reduce admission rate. It is also of the nurses

concern if any rapid pain reduction method can help pediatric intravenous

cannulation. Therefore, most of the colleagues should support this innovation.

23

The innovation procedure is simple. Also, as mentioned above, A&E nurses have

been trained to administer topical anesthesia. Therefore, they do not need

complicated, time-consuming training. They should be able to operate the

innovation device after a few minutes of briefing given by the sales representative

from the medical device company.

For the assessment and evaluation of pain, NTWC has a unique pain assessment

policy (2009) and tools combining the Numeric Rating Scales (NRS), Verbal

Description Scales (VDS), Wong-Baker FACE scale and

Face-Legs-Activity-Cry-Consolability (FLACC) scales (Appendix 6). The pain

levels of patients with various ages, including infants, can be measured with the

assessment tool.

3.1.3 Cost-benefit ratio of the innovation

A successful innovation should not only be effective, but should also be

cost-effective. Therefore, examination of the cost-benefit ratio is crucial. In this

section, the risks and benefits, as well as costs of the innovation will be assessed

and compared to the current practice.

24

As mentioned in the previous sections, the innovation may have adverse effects.

These include erythema, edema and pruritus. However, the incidence rates of the

adverse effects, as evident from the reviewed studies, are very low. Moreover, the

innovation can reduce pain within a short period of time. It can also provide faster

investigation, diagnosis and treatment. Ultimately, it can reduce admission and

other related healthcare expenses.

The issues of overloading and nursing shortage in the pediatric wards are not new.

These often lead to overcrowding of the emergency departments. If the innovation

is not implemented, this situation will remain unchanged. In addition, more

children would suffer from pain and distress, and it may also delay the diagnosis

and treatment.

Time also costs. Among the anesthesia mentioned in Chapter 2, only three of them,

namely the J-Tip injector, Sonoprep and Er:YAG laser can provide adequate

anesthetic effect in five minutes (Singer et al., 2006; Skarbek-Borowska et al.,

2006; Spanos et al.,2008). Therefore, only those three innovations are selected for

further cost-benefit analysis.

25

As shown in Appendices 7 to 9, there would be no setup cost for the J-Tip injector,

while the setup cost for the Sonoprep and Er:YAG innovation would be

HK$15,561 and HK$668,145.97 respectively. The running cost of the J-Tip

injector, Sonoprep and Er:YAG laser innovation would be HK$76,022.7,

HK$196,872 and HK$99,216 per year respectively. The total material costs of the

J-Tip injector, Sonoprep and Er:YAG laser innovation would be HK$76,022.7,

HK$212,433 and HK$767,361.97 in the first year respectively. The analysis result

is consistent with the cost-effectiveness analysis study, which also found that

J-Tip injector is one of the most cost-effective anesthetic devices (Pershad,

Steinberg & Waters, 2008). Hence, the J-Tip injector would be our option of

innovation.

Appendix 10 shows the staff cost for the innovation project setup. The

development phase needs one Advanced Practice Nurse (APN) as nurse specialist

and three registered nurses (RN). The RNs would spend ninety hours in meetings,

developing the guideline, conducting the pilot study and audit, and the evaluation

of implementation. In addition, the APN would hold the meetings. A total of one

hundred hours corresponding to HK$12783.6 would be spent as setup cost.

26

Appendix 11 shows the hidden cost and the estimated cost of the innovation. The

cost for nurses to administer anesthesia, assess pain level and adverse effects are

excluded. It is because A&E nurses can do other tasks when the patients are

waiting for the onset of the drug. Therefore, the cost of administering the

innovation would be minimal. The training session and meetings would be held in

the hospital premises, and the existing computer and software for data analysis in

the emergency department would be used, so those costs are also excluded.

Therefore, the estimated setup cost of innovation would be HK$12,783.6 and the

running cost would be HK$76,022.7 per year. A total of HK$88,806.3 would be

spent in the first year.

Appendix 12 shows the cost of the current practice. According to the Annual

Report of the Hospital Authority (2010a), cost of one patient-day is HK$3,590 and

the average length of stay of a pediatric in-patient is five days. Assuming that 150

out of 1,565 pediatric admissions can be reduced, the cost reduction would be

HK$2,692,500. In other words, more than HK$2.6M can be saved every year. In

addition, the new innovation can bring other potential benefits. For instance, it can

relieve the already crowded pediatric ward and the emergency department; foster

early diagnosis and treatments for patients; and as a result, reduce the morbidity

27

and mortality rate.

3.2 EVIDENCE-BASED PRACTICE GUIDELINE

The next step of the translational process is to develop a practice guideline

according to the best evidence available (Polit & Beck, 2008).

The methodology of guideline development recommended by the SIGN was used.

SIGN 50: A Guideline Developers’ Handbook (2011) is referred as guidance.

Appraisal of Guidelines Research and Evaluation II (AGREE II) Instrument has

been developed for the evaluation of methodological quality of guidelines (The

AGREE Next Steps Consortium, 2009). Although it is not possible to do this

since there is no existing guideline for topical anesthesia for pediatric

venipuncture in the emergency departments, it can be also seen as guidance for

guideline development. It includes 6 domains: scope and purpose; stakeholder

involvement; rigor of development; clarity of presentation; applicability; and

editorial independence.

The patient involvement and the establishment of the guideline development

group were not done in the development process due to the constraints of time and

28

resources. However, the selection of topic, systematic literature review and

evidence synthesis can be found in Chapters 1 and 2 respectively.

Recommendation forms an essential part of a guideline. Levels of evidence and

grades of recommendation should be assessed. Level of evidence of the reviewed

original studies can be found in Chapter 2. Grades of recommendations were

assessed by SIGN 50: A Guideline Developers’ Handbook (2011). The

evidence-based guideline with its recommendations is attached in Appendix 13.

29

CHAPTER 4: IMPLEMENTATION PLAN

4.1 COMMUNICATION PLAN

In Chapter 3, it is shown that the innovation is transferable and feasible but some

potential barriers are identified. To deal with the resistance during the

implementation of the innovation, an organized and effective communication and

implementation strategy is crucial (Palda, Davis, & Goldman, 2007).

4.1.1 Identification of Stakeholders

Identification of stakeholders can facilitate the change of practice as their

cooperation can affect the success of the innovation (Registered Nurses

Association of Ontario, 2002). The COS and the DOM are the important

stakeholders. They are the policy and decision makers and can provide

administrative support and resources. The COS would arrange medical manpower

and would be responsible for the approval of the implementation and budget plan.

The DOM would arrange nursing manpower for the implementation of the

innovation. Around one hundred frontline staff, including thirty-five medical

officers and sixty-five nurses, are also stakeholders as they are the users as well as

the conductors of the program. Their support and opinions are very important for

30

the establishment of a feasible guideline. The cooperation with the pharmacy

department is also essential since the pharmacists would be responsible for price

quotation, storage and management of anesthesia.

4.1.2 Strategies of Change: Initiation, Guiding and Sustaining

Appendix 14 shows the Gantt chart of the implementation plan. The duration of

the whole implementation plan would be fourteen months.

The nurse specialist, also acts as the program coordinator, frequently gives advice

for the practice for change and so he would be the proposer to sell the proposal. In

the first week, the proposed issues would be raised among the twelve APNs by the

nurse specialist during the breaks, handover time and informal meetings. The need

of change would be affirmed. After persuading the APNs, the issue would be

raised by the nurse specialist in an informal meeting with the COS and the DOM

in the second week of the implementation plan. At the policy level, the vision,

mission and values of the target hospital is “People FIRST” where the “I” refers to

innovation. Moreover, as mentioned in Chapter 3, the COS and the DOM are

innovative persons who welcome change for better practice. As the integrative

review and the cost-benefit analysis show that the proposed innovation is cheap,

31

effective and have potential benefits, they should be interested in the innovation.

In the third week, a formal intra-departmental meeting would be held with the

COS and the DOM. Timeframe and details of the implementation, pilot test and

evaluation plan would be discussed.

On the other hand, the atmosphere with the need of change has to be created.

Other than persuading the APNs, the nurse specialist should be responsible to help

disseminate the importance of change and the current evidence to the frontline

staff by weekly emails and the departmental training which would be held in the

third week of the plan. During breaks and handover time of every shift, informal

discussions to raise the awareness of doctors and nurses for the existing problem

of pediatric intravenous cannulation would also be initiated. All members of the

working group, including the DOM, COS, nurse specialist and three RNs who

work on the guideline development, would form a communication team. The team

would help to further promote the innovation with the existing evidence to the

staffs. This can be done by holding introductory talks during the monthly

departmental training in the third week,and hoisting posters in the staff pantry by

the fourth week of the plan. After the innovation plan is approved by the ethics

approval board, the team members will also be trained to use the jet device so that

32

they can train other frontline staff in the pilot phase.

After discussion with all the stakeholders, a formal proposal would be made by

the working group in the fifth week. At the end of the fifth week, the proposal

would be sent for approval by the COS and the DOM. After that, the proposal

would be sent to the ethics approval board of the target hospital for approval of

pilot test. The approval process by the ethics approval board usually takes 6

weeks.

To guide and sustain the change, the innovation would be encouraged and

promoted by nursing officers during the handover time in the first two weeks of

the pilot phase and the implementation phase. Reminders for the use of innovation

would be posted in every cubicle to encourage the frontline users to perform

intravenous cannulation during the pilot phase. An educational video for the use

of the jet device would also be produced by the working group and would be

posted to the equipment webpage. A short quiz will be given in the seventh month.

All frontline users would be required to watch the video and complete the quiz

before the implementation phase in the eighth month. When the implementation

phase begins, the user guide, together with the FAQs and the protocol would be

33

made and disseminated via email by the working group. An opinion sheet

(Appendix 15) would be posted in the emergency cubicle during the pilot phase

and the implementation phase. The frontline staff can then express their opinions

and suggestions which would be considered in polishing the guideline.

4.2 PILOT PLAN

Pilot test is an important component of the innovation. It can help to examine the

feasibility of the proposed protocol. It is the rehearsal of the implementation so

the workflow of the guideline and the data collection method can be tested. Staff

opinions would be collected during the pilot test. As a result, the proposed

guideline and evaluation method can be revised for better arrangement and

administration.

4.2.1 Design

The whole pilot plan would last for ten weeks, including a two-week training

period, a three-week observational period, a three-week intervention period and an

eight-week amendment period. An observation period is used to determine the

pain level in pediatric patients undergoing intravenous cannulation in the target

setting. Thus, all subjects in the period would receive the usual care, i.e. they

34

would have cannulation without anesthesia. During the intervention period,

trained nurses would perform the intervention by following the protocol.

4.2.2 Subjects

The inclusion and exclusion criteria of subjects for both the observational stage

and the interventional stage would be the same as in the proposed protocol. All

pediatric patients who are five to eighteen years old and require intravenous

cannulation would be included, except those who have mental illness, allergy of

lidocaine or have received analgesia. Approximately eighty subjects would be

included in each of the observational group and interventional group.

4.2.3 Preparation

At the twelfth week, a salesman of the jet device would be invited to introduce

and train the members of the working group on to the proper usage of the device.

Eighty sets of the jet devices would be purchased for use in the pilot and

implementation periods. In the next two weeks, members of the working group

will hold group training sessions for the frontline users when they are on duty. The

training will be on the protocol, measuring instrument and the data collection

method. All frontline users are required to complete the training by the fourteenth

35

week.

4.2.4 Measurements

Just after cannulation, pain score would be assessed by the procedure nurse and

patient data would be collected by a data collection form (Appendix 16). Sex, age,

race, size of cannula used, location of cannulation, adverse events and disposal

destination would be documented. Pain would be assessed by the NTWC pain

assessment tool (Appendix 6), combining with the Numeric Rating Scale (NRS),

Verbal Descriptive Scale (VDS), and Wong-Baker FACE Scale (WBFS) (Hospital

Authority, 2009). For those who are not able to express properly,

Face-Legs-Activity-Cry-Consolability (FLACC) scale would be used. NRS, VDS

and FLACC scale are proven to be reliable and valid. (Bai, Hsu, Tang & van Dijk,

2012; Summers, 2001; Ramelet, Rees, Mcdonald, Bulsara, & Huijer, 2007) WBFS

has high agreement with the visual analog scale and has been validated for use in

children. (Anthony & Schanberg, 2007; Garra et al., 2010)

Completed forms would be collected in a box in the nursing station. Members of

the working group would act as observers, and are responsible for the audit and

documentation of any violation of protocol or discrepancies in practice among the

36

procedure nurses. As mentioned, there would be a staff opinion form in the

emergency cubicle during the pilot test period, frontline users are encouraged to

provide opinions and advices about the innovation. Members of the working

group would also give feedback with the form. The form would be collected at the

end of twentieth week.

4.2.5 Review of guideline

At the end of pilot test, all the data collection forms, audit notes and opinion

forms would be collected. A review board would be formed by the COS, DOM,

nurse specialist and members of the working group. Obstacles of workflow,

potential problems of data collections, advices from the users and observations

from the auditors would be discussed in the review meeting. According to the

evaluation, amendments would be made within a week. The amended guideline

would be sent to the ethics approval board again for approval before proceeding to

the implementation phase. A two-week training on the amended guideline during

the departmental training sessions would be finished at the end of thirtieth week.

4.3 EVALUATION PLAN

Evaluation of innovation is an essential part. It can tell if the innovation is

37

effective, efficient and deserves continuation. Appendix 17 shows the summary of

the evaluation. The proposed outcomes, measuring tools and frequency, objectives

for measurement, methods of analysis and the target of basis of change are listed

in the summary

4.3.1 Outcomes and measurements

The primary patient outcome would be the pain score. As described in the pilot

plan,the procedure nurse would measure pain by the NTWC pain assessment tool

and document in the pediatric intravenous cannulation record (Appendix 16). The

NTWC pain assessment tool (Appendix 6) includes NRS, VDS and WBFS

(Hospital Authority, 2009). For those who are unable to express properly, FLACC

scale would be used. NRS, VDS and FLACC scale are proven to be reliable and

valid (Bai, Hsu, Tang & van Dijk, 2012; Summers, 2001; Ramelet, Rees,

Mcdonald, Bulsara, & Huijer, 2007). WBFS has high agreement with the visual

analog scale and has been validated for use in children (Anthony & Schanberg,

2007; Garra et al., 2010).

The secondary patient outcomes would be the number of admissions of the target

population and the length of stay. Data of admission can be collected in the

38

pediatric intravenous cannulation record (Appendix 16). The length of stay would

be obtained by the electronic patient record. One of the group members would be

responsible for extracting the data.

The healthcare provider outcome would be staff satisfaction. Staff satisfaction

would be assessed with a self-reported survey (Appendix 18). The survey has a

5-point Likert scale, from 1(strongly disagree) to 5(strongly agree). A mean score

would be calculated as the final score of the survey. The higher the score is, the

more satisfied the staff member is about the innovation.

The system outcomes would be the utilization rate of the innovation and cost of

the innovation. The utilization rate would be obtained by the electronic patient

record. Cost would be calculated by the account record, which is kept by the

secretary of the target department and the ward manager, for material cost and

compensation hour record for staff cost. An A&E secretary would help to extract

the records.

Other demographic data would be collected and documented in the pediatric

intravenous cannulation record (Appendix 16).

39

4.3.2 Nature and number of clients to be involved

The inclusion and exclusion criteria of clients would be the same as the protocol

discussed before. All pediatric cases who need intravenous cannulation would be

included, except those who have mental illness, allergy of lidocaine or have

received analgesia.

From the previous studies, it is found that a minimum reduction of ten millimeters

in VAS (equivalent to one unit in the NTWC pain assessment tool, see Appendix 6)

would be considered as an important effect of the innovation (Powell, Kelly

&Williams, 2001). Assuming the standard deviation be three units, effect size d be

0.9, power be 0.8 and alpha be 0.05, the estimated sample size would be 73. Since

there are about 1565 eligible subjects per year, the expected time to achieve 73

subjects would be three weeks.

However, with special considerations mentioned in the next section, the total

number of patients involved would be 783. Since there are around one hundred

frontline staffs in the emergency department, three weeks may not be enough to

provide adequate exposure for all staff. On the other hand, it is difficult to reflect

40

the secondary outcomes and cost within such a short period. Therefore, a

twenty-six-week implementation period would be preferred. As the estimated

number of eligible clients would be 1,565 annually, the estimated number of

patients to be enrolled in the implementation period would be 783.

4.3.3 Timing and frequency of taking measurements

Primary outcome would be measured just after each procedure, and the data of

secondary outcomes and cost would be collected at the end of the implementation

period, i.e. week 26. Staff satisfaction and utilization rate would be collected in

the middle (week 13) and the end of implementation phase (week 26).

4.3.4 Data analysis

In the fifty-ninth week of the implementation plan, data would be entered to a

computer database and analyzed by one of the working group members who has

been trained with the IBM SPSS software. Two-tailed t-test would be used to

determine if the pain score is reduced in the innovation group compared to the one

in the current practice, i.e. the one obtained in the observational period in the pilot

study. Two-tailed t-test would be used to determine if the admission rate and the

length of hospital stay would be reduced when compared with that during the

41

same period in the last year. The nominal level of significance of the significant

tests mentioned above would be 0.05. The staff satisfaction towards the

innovation in week 13 and week 26 would be estimated with 95% confidence

interval. 95% confidence interval would also be used to determine the utilization

rate estimation. Cost would be calculated by the sum of the setup cost. It includes

the personnel cost and the material cost for the purchases of devices and materials,

and the miscellaneous cost for the purchase of ink, paper, etc.

4.3.5 Basis for adopting innovation

It is a crucial part of the evaluation to determine if the innovation would be

adopted. The working group members would hold an evaluation meeting with the

COS and the DOM at the end of the evaluation period, i.e. sixtieth week. During

the meeting, they would discuss about the results from the data analysis. As

mentioned, a minimum reduction of one unit of pain in the NTWC pain

assessment tool compared to the current practice would be considered as a

significant difference. For the admission rate and the length of hospital stay, it is

estimated that the innovation can provide a reduction of 10% in the admission rate

and 0.5 patient-day of hospital stay compared to the same period last year. Staff

should at least have a mean satisfaction score of three out of the 5-point Likert

42

scale, meaning that they do not disagree with the use of the innovation. The

utilization rate should be over 80%. And the actual cost of innovation should be

estimated by the setup cost (HK$ 12,783.6), material cost for pilot and

implementation periods (HK$ (783+80)X(2.1+4)X7.8= HK$41,061.5), and the

miscellaneous cost (HK$ 1560), i.e. HK$44405.1.

43

APPENDICES Appendix 1 Searching Strategies for Existing Guidelines/ Protocols

Guideline Database

National Guideline

Clearinghouse (NGC)

CMA InfoBase

Health Services/

Technology Assessment

Text (HSTAT)

Guidelines Advisory

Committee (GAC)

Scottish Intercollegiate

Guideline Network (SIGN)

National Insitute for

Clinical Excellence

(NICE)

New Zealand

Guidelines Group

(NGZZ)

Guidelines International

Network

Date of Search 30/8/2011 Keywords: anesthesia AND Vein catheterization OR Venous catheterization OR Vascular access OR Venous access OR Venipuncture OR Venepuncture OR cannulation OR needle insertion

0 0 0 0 0 0 0 0

Appendix 2 Searching Strategies for Systematic Reviews Database for Systematic Reviews Cochrane Library Date of Search 2/9/2011 Searching Criteria Number of Reviews 1. Keywords:

Topical anesthesi* OR Local anesthesi* 14

2. Keywords: Vein catheterization OR Venous catheterization OR Vascular access OR Venous access OR Venipuncture OR Venepuncture OR cannulation OR needle insertion

48

3. Keywords: Emergency department OR emergency service OR emergency setting OR ED

91

1 AND 2 AND 3 0

44

Appendix 3 Searching Strategies for Primary Studies

Database PubMed CINAHL Embase

Date of Search 2/9/2011 30/8/2011 2/9/2011

Searching Criteria Number of Articles

1. Keywords:

Topical anesthesi* OR Local

anesthesi*

20178 967 35350

2. Keywords:

Vein catheterization OR Venous

catheterization OR Vascular access

OR Venous access OR

Venipuncture OR Venepuncture

OR cannulation OR needle

insertion

207432 4769 41331

3. Keywords:

Emergency department OR

emergency service OR emergency

setting OR ED

808895 35800 88493

1 AND 2 AND 3 52 3 32

Subtotal 87

Limited to :

Randomized Controlled Trial

20

3

(only 1 result in

automatic limits,

but all 3 articles

are RCTs)

18

Limited to :

Ages: All Infant: birth-23 months, All

Child: 0-18 years, Newborn: birth-1

month, Infant: 1-23 months, Child: 6-12

years, Adolescent: 13-18 years

(PubMed);

Age Groups: Infant, Newborn: birth-1

month, Infant: 1-23 months, Child,

Preschool: 2-5 years, Child: 6-12 years,

Adolescent: 13-18 years, All infant, All

Child (CINAHL);

Human Age Groups: infant <to one

year> or child <unspecified age> or

10 3 11

45

preschool child <1 to 6 years> or school

child <7 to 12 years> or adolescent <13

to 17 years> (Embase)

Articles remained after screening title

and abstract 8 2 8

Full text available or relevant data

available in abstract 8 2 8

Articles remained after screening full

paper 7 1 8

Articles remained after removal of

duplicated with other databases 7 0 5

Plus articles from references of eligible

studies 1

Total 13

46

Appendix 4

Table of Evidence

Study, Year

(Number in

List of

articles)

Study Design,

Number of

subjects,

Level of

Evidence

Subject

characteristics

(Intervention vs

Comparison)

Intervention Comparison/

Control

Length

of

follow

up

Outcome measures

(Unit / scale of

measurement)

Effect size

(Intervention vs Comparison)

Arendts et

al., 2008,

(1)

RCT, n=203,

1+

Mean age: 4.9

vs 4.8; Range:

0-12 vs 0-13

Sex:

M=38vs55,

F=39vs42

EMLA applied

on the right

dorsal hand and

antecubital fossa

under occlusive

dressing

Cannulating

staff choose site

of cannulation

n=93

Withdrawn n=13

Analyzed n=80

AnGEL applied

on the right

dorsal hand and

antecubital fossa

under occlusive

dressing

Cannulating

staff choose site

of cannulation

n=110

Withdrawn n=13

Analyzed n=97

60 min Primary:

1. Initial cannulation

success rates (%)

Secondary:

2. Safety (No. of

adverse events)

1. 74 vs 75 (p=0.82)

2. 3(4%) vs 13 (13%)

Auerbach

et al., 2009,

(2)

RCT, n=197,

1+

Mean age

±SD:

(a)11.7±4.0 vs

(a) Jet lidocaine

injection

n=75

(b) Jet placebo

(normal saline)

injection

30 sec

- 5 min

Primary:

1. Pain by CAS

(mm)

1. Pain score (95% CI)

i. (a) 12(7-17) vs (b)

27(20-34) (p<0.01)

47

(b)12.4±4.2 vs

(c)12.5±4.1

Sex (%):

M= (a)52 vs

(b)52 vs (c)40,

F= (a)48 vs

(b)48 vs (c)60

n=75

(c) no

pretreatment

n=47

i. Device

application

ii. Needle

insertion

iii. 5 min after

needle

Secondary:

2. Safety (No. of

adverse events)

ii. (a) 28(21-35) vs

(b) 24(27-41) vs

(c) 52(43-60)

(a vs b: p=0.23; a vs c:

p<0.01; b vs c: p<0.01)

iii. (a) 12(7-17) vs (b)

12(7-17) vs (c) 15(8-21)

(p>0.05)

2. None.

Costello et

al., 2006,

(3)

RCT, n=127,

1+

Mean age:

(a)12.7 vs

(b)13.3 vs

(c)13.2

Sex (%):

M= (a)41 vs

(b)48 vs (c)50,

F= (a)59 vs

(b)52 vs (c)50

(a) ethyl vinyl

chloride

vapocoolant

spray

n=37

(b) isopropyl

alcohol spray

n=48

(c) no

pretreatment

n=42

5 sec Primary:

1. Pain in VAS

(mm)

Secondary:

2. Initial cannulation

success rate (%)

3. Safety (No. of

adverse events)

1. (a)34±26 vs (b)33±25 vs

(c)31±25 (p=0.8)

2. (a)78 vs (b)85 vs (c)86

(p=0.6)

3. None.

Kim et al.,

1999, (4)

RCT, n=50,

1-

Mean age:

11.4 vs 10.6

Sex:

M= 10(45%)

vs 11(44%),

2% lidocaine

with 1:100,000

epinephrine

(Iontocaine) in

drug electrode

0.9% saline

solution with

1:100,000

epinephrine in

drug electrode

After

i.v.

cannul

ation

to 48

Primary:

1. Pain in

iontophoresis

2. Pain in

cannulation in

1. No discomfort:

9(39%) vs 6(22%)

Slightly uncomfortable:

13(57%) vs 17(63%)

Uncomfortable: 1(4%) vs

48

F= 12(55%) vs

14(56%)

administered by

a

battery-operated

iontophoresis

unit

n=23

withdrawn n=1

analyzed n=22

administered by

a

battery-operated

iontophoresis

unit

n=27

withdrawn n=2

analyzed n=25

hrs VAS (unit)

Secondary:

3. Cannulation

success rates (%)

4. Safety (No. of

adverse events)

2(7%)

Very uncomfortable:

0(0%) vs 1(4%)

Painful: 0(0%) vs 1(4%)

2. Median (25th and 75%

percentiles):

0.5(0-2) vs 4(2-8) (p=0.002)

3. 77 vs 84

4. 6 vs 2

Luhmann et

al., 2004,

(5)

RCT, n=69,

1++

Overall Mean

Age ± SD

(range):

12.1±4.5

(4.3-20.3)

Overall sex

(%):

M=39, F=61

Buffered

lidocaine

administered

subcutaneously,

5min before

cannulation

n=34

ELA-Max

applied to skin

with tegaderm

occlusion, 30

min before

cannulation

n=35

5min –

30 min

Primary:

1. Pain in

cannulation in

VAS (unit)

2. Anxiety in

cannulation in

VAS (unit)

1. Children:

3.4±2.9 vs 2.6±2.5 (p=0.19)

Parents:

3.3±2.5 vs 2.5±2.2 (p=0.17)

Blinded Observer:

2.0±1.4 vs 2.5±1.8 (p=0.2)

2. Children:

2.9±3.2 vs 2.0±2.0 (p=0.18)

Parents:

2.6±2.7 vs 2.2±2.0 (p=0.50)

Blinded Observer:

3.3±2.5 vs 3.3±2.5 (p=0.96)

Mann et al.,

2007, (6)

RCT, n=101,

1-

Age

range:3-15

EMLA

application

Nitrous oxide

administration

About

12

Primary:

1. Pain in

1. Median(IQR):

1(1-2) vs 1(0-2) (p = 0.85)

49

n=45 n=56 minute

s

cannulation in

Wong-Baker

FACES pain

rating scale (unit)

Secondary:

2. Safety (No. of

adverse events, %,

95%CI)

2. 1 (2.2, 0.1-13.2) vs 8(14.3,

6.8-26.8)

Newbury et

al., 2009,

(7)

RCT,n=679,

1++

Mean Age

(SD):

6y9m(4y3m)

vs 7y0m

(4y2m)

Sex:

M=168(50%)

vs 187(54%),

F=162(48%)

vs 153(45%)

Amethocaine

(Ametop)

applied and

covered with

transparent

adhesive

dressing for 45

min

n=337

EMLA applied

and covered

with transparent

adhesive

dressing for 90

min

n=342

45-90

min

Primary:

1. Initial cannulation

success rate (%)

Secondary:

2. Pain in VAS and

FLACC (units)

1. 75.8 vs 73.9 (p=0.56)

2. Pain score shown in graph,

exact numeric score not given.

But statistically insignificant.

(p>0.05)

Ramsook et

al., 2001,

(8)

RCT,n=222,

1+

Median Age: 9

vs 10

Sex (%):

M=44 vs 47,

F=56 vs 53

Ethyl chloride

aerosol sprayed

5 sec before

cannulation

n=114

Isopropyl

alcohol aerosol

sprayed 5 sec

before

cannulation

5 sec Primary:

1. Pain in

cannulation with

Faces Pain Scale

and Numeric Pain

1. Median:

3-5yr-old= 6 vs 6,

6-12yr-old= 4 vs 4,

>12yr-old= 2 vs 3

2. Median: 0 vs 0

50

3-5yr-old n=25,

6-12yr-old

n=63,

>12yr-old n=26

n=108

3-5yr-old n=19,

6-12yr-old

n=59,

>12yr-old n=30

Scale (units)

2. Pain in spray with

Faces Pain Scale

and Numeric Pain

Scale (units)

Secondary:

3. Initial cannulation

success rate (%)

3. 76 vs 85

Shavit et

al., 2009,

(9)

RCT,n=40,

1+

Mean Age:

13.6 vs 14.12

1-2g of LidoDin

applied to

antecubital

fossa, covered

with dressing for

60 min then

removed

Cannulation

after several

minutes of

cream removal

n=20

1-2g of EMLA

applied to

antecubital

fossa, covered

with dressing for

60 min then

removed

Cannulation

after several

minutes of

cream removal

n=20

1-5

min

after

cream

remov

al and

immed

iately

after

cannul

ation

Primary:

1. Pain in VAS

(mm)

2. Safety in

Numerical Scale

for Skin

Assessment (unit)

i. Erythema

ii. Edema

iii. Pruritus

1. Patient assessment, Mean

(SD):

11.1(7.2) vs 10.5(10.5)

(p=0.87)

Nurse assessment, Mean (SD):

7(6.5) vs 8(8.9) (p=0.69)

2. Mean:

i. 0.35 vs 0.25 (p=0.73)

ii. 0.5 vs 0.4 (p=0.75)

iii. 0 vs 0

Singer et

al., 2008,

(10)

RCT,n=40,

1+

Mean age

(SD):

9.3(4.3) vs

Lidocaine 70mg/

tetracaine 70mg

topical patch

Placebo patch

applied over

vein at triage.

Just

after

cannul

Primary:

1. Pain in VAS

(mm) or

1. Median score (IQR):

All patients:

18(1-40) vs 35(20-59)

51

10.8(4.5)

Sex:

M= 13(65%)

vs 13(45%),

F= 7(35%) vs

7(35%)

applied over

vein at triage.

Patch removed

before

cannulation

n=20

Patch removed

before

cannulation

n=20

ation Wong-Baker

FACES pain

rating scale (unit)

Secondary:

2. No. of successful

cannulation

3. No. of very easy

cannulation

4. No. of adverse

events

i. Erythema

ii. Edema

iii. Pruritus

(p=0.04)

Patients using VAS:

11(0-30) vs 39(20-61)

(p=0.01)

2. 18(90%) vs 17(85%) (p=1.00)

3. 14(70%) vs 18(90%) (p=0.24)

4. Erythema 6(30%) vs 6(30%)

(p=1.00)

Edema: 0 vs 0

Pruritus: 0 vs 0

Singer et

al., 2006,

(11)

RCT,n=61,

1+

Mean age

(95%CI):

27(19,35) vs

27(20,35)

No. of

children:

15(50%) vs

15(50%)

Sex:

M= 17(57%)

Laser applied

over vein for

600

microseconds.

0.5g ELA-Max

cream applied

by cotton-tipped

applicator.

Cream wipe off

after 5 min.

Sham laser

applied over

vein for 600

microseconds.

0.5g ELA-Max

cream applied

by cotton-tipped

applicator.

Cream wipe off

after 5 min.

Just

after

cannul

ation

to one

week

later

Primary:

1. Pain for (a)

laser/sham

application and

(b) venous

cannulation in

VAS (mm) for

subject aged ≧8,

Smiley Analog

Scale (unit) for

1. Mean score (95%CI):

Adult:

(a) 0 vs 0

(b) 5.6(1.4,9.8) vs

35.9(21.1,50.6)

Children:

(a) 3.1(0,7.5) vs 0

(b) 14.4(3.9,25.0) vs

40.9(29.3,52.4)

All patients:

52

vs 14(45%),

F= 13(43%) vs

17(55%)

n=30 n=31 subject aged 3-7,

CHEOPS (unit)

for subject aged

<3

Secondary:

2. No. of successful

cannulation

3. No. of very easy

cannulation

4. No. of adverse

events

(a) 1.5(0,3.7) vs 0

(b) 10.0(4.4,15.6) vs

38.3(29.3,42.2)

2. Adult: 14(93.3%) vs

14(87.5%) (p=0.23)

Children: 13(87%) vs 8(53%)

(p=0.006)

All patients: 27(90%) vs

22(71%) (p=0.001)

3. Adult: 12(80.0%) vs

10(62.5%) (p=0.43)

Children: 10(67%) vs 7(47%)

(p=0.20)

All patients: 22(73) vs 17(54)

(p=0.01)

4. Adult: 0 vs 0

Children: 0 vs 0

All patients: 0 vs 0

Skarbek-Bo

rowska et

al., 2006,

(12)

RCT,n=77,

1++

Mean

Age(SD):

13.08(2.39) vs

12.62(2.55)

Sex:

sonophoresis

with SonoPrep

4% liposomal

lidocaine cream

(ELA-Max)

sonophoresis

with SonoPrep

placebo cream

applied 5 min

before

Just

after

ultraso

und

applica

Primary:

1. Pain in VAS

(mm)

Secondary:

2. Frequency of skin

1. Mean Score(SD)

Child: 2.29(1.82) vs

3.23(2.23) (p=0.023)

Parent: 2.47(2.18) vs

3.39(2.38) (p=0.038)

53

M=17(45%) vs

20(51%),

F=21(55%) vs

19(49%)

applied 5 min

before

cannulation

n=38

cannulation

n=39

tion to

48

hours

redness

i. Immediate after

sonication

ii. 24 hours after

sonication

3. Sensation of

device

(Frequency)

4. Difficulty in

cannulation

(Frequency)

Nurse: 1.29(0.71) vs

1.49(0.60) (p=0.103)

2. Frequency (%):

i. No effect: 19(50.0) vs

22(56.4)

Minor: 18(47.4) vs 16(41.0)

Significant: 1(2.6) vs 1(2.6)

(p= 0.821)

ii. No effect: 37(97.4) vs

37(97.4)

Minor: 1(2.6) vs 1(2.6)

Significant: 0 vs 0

(p=1.00)

3. No discomfort:

21(55%) vs 22(56%)

Little uncomfortable:

11(29%) vs 11(28%)

Uncomfortable: 5(13%) vs

5(13%)

Very uncomfortable:

1(3%) vs 0(0%)

It hurt: 0(0%) vs 1(3%)

(p=1.00)

54

4. Easy: 31(81.6%) vs 35(89.7%)

Slightly difficult:

4(10.5%) vs 2(5.1%)

Very difficult: 3(7.9%) vs

2(5.1%)

(p=0.578)

Spanos et

al., 2008,

(13)

RCT,n=70,

1++

Mean Age

(SD):

12(2.4) vs

12(2.2)

Sex:

M=17(49%) vs

18(51%),

F=18(51%) vs

17(49%)

J-Tip jet

injection of 1%

buffered

lidocaine 5 min

before

cannulation

n=35

ELA-Max cream

applied 30 min

before

cannulation

n=35

5-30

min

Primary:

1. Pain of

cannulation in

VAS (mm)

2. Pain of jet

injection in VAS

(mm)

Secondary:

3. Difficulty of

cannulation

(Scale: 1 = very

easy, 2 = easy, 3 =

moderate, 4 =

difficult, 5 = very

difficult.)

4. Initial successful

cannulation

1. Mean(SD), Median Score:

Patient: 17.3(26.7),4 vs

44.6(35.1),39 (p<0.001)

Blinded observer:

21.7(30.9),5 vs 31.9(30.7),35

(p=0.23)

2. Patient:

Mean Score(SD): 3.83(12.1)

No. of pain=0mm: 26(74%)

No. of pain<10mm: 32(91%)

Blinded observer:

Mean Score(SD): 3.57(6.0)

No. of pain=0mm: 23(66%)

No. of pain<10mm: 31(89%)

3. Mean(SD): 2.0(1.1) vs

2.3(1.3) (p=0.27)

4. 22(63) vs19(54)

55

(Frequency, %)

Abbreviations

CAS = Color Analog Scale

CHEOPS=Children’s Hospital of Eastern Ontario Pain Scale

IQR = InterquartileRange

RCT = Randomized Contolled Trial

SD = Standard deviation

VAS = Visual Analog Scale

List of articles

1. Arendts, G., Stevens, M. & Fry, M. (2008). Topical anaesthesia and intravenous cannulation success in paediatric patients: A randomized double-blind trial. British Journal of

Anaesthesia, 100, 521-524. doi:10.1093/bja/aen003

2. Auerbach, M., Tunik, M. & Mojica, M. (2009). A randomized, double-blind controlled study of jet lidocaine compared to jet placebo for pain relief in children undergoing needle

insertion in the emergency department. Academic Emergency Medicine, 16, 388-393. doi:10.1111/j.1553-2712.2009.00401.x

3. Costello, M., Ramundo, M., Christopher, N.C. & Powell, K.R. (2006). Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in

children. Clinical Pediatrics, 45, 628-632. doi:10.1177/0009922806291013

4. Kim, M.K., Kini, N.M., Troshynski, T.J. & Hennes, H.M. (1999). A randomized clinical trial of dermal anesthesia by iontophoresis for peripheral intravenous catheter placement in

children. Ann Emerg Med, 33(4), 395-359.

5. Luhmann, J., Hurt, S., Shootman, M. & Kennedy, R. (2004). A comparison of buffered lidocaine versus ELA-Max before peripheral intravenous catheter insertions in children.

Pediatrics, 113(3 Pt 1), e217-e220.

6. Mann, T., Taylor, D.McD. & Smit, P.D.V. (2007). Eutectic mixture of local anaesthetics vs nitrous oxide for cannulation of children in the emergency department. Journal of

Pharmacy Practice and Research, 37(4), 281-283. Retrieved September 2, 2011, from

http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed8&NEWS=N&AN=2008089643.

7. Newbury, C. & Herd, D.W. (2009). Amethocaine versus EMLA for successful intravenous cannulation in a children's emergency department: a randomised controlled study. Emerg

56

Med J, 26, 487-491. doi:10.1136/emj.2008.065110

8. Ramsook, C., Kozinetz, C.A. & Moro-Sutherland, D. (2001). Efficacy of ethyl chloride as a local anesthetic for venipuncture and intravenous cannula insertion in a pediatric

emergency department. Pediatric Emergency Care, 17, 341-343. doi:10.1097/00006565-200110000-00005

9. Shavit, I., Hadash, A., Knaani-Levinz, H., Shachor-Meyouhas, Y. & Kassis, I. (2009). Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for

venipuncture: A randomized controlled trial. Clinical Journal of Pain, 25, 711-714. doi:10.1097/AJP.0b013e3181a689ec

10. Singer, A.J., Taira, B.R., Chisena, E.N., Gupta, N. & Chipley, J. (2008). Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized

controlled trial. Ann Emerg Med, 52(1), 41-47.

11. Singer, A.J., Weeks, R. & Regev, R. (2006). Laser-assisted anesthesia reduces the pain of venous cannulation in children and adults: a randomized controlled trial. Acad Emerg

Med,13(6), 623-628.

12. Skarbek-Borowska, S., Becker, B.M., Lovgren, K., Bates, A. & Minugh, P.A. (2006). Brief focal ultrasound with topical anesthetic decreases the pain of intravenous placement in

children. Pediatric Emergency Care, 22, 339-345. doi:10.1097/01.pec.0000216566.33747.5b

13. Spanos, S., Booth, R., Koenig, H., Sikes, K., Gracely, E. & Kim, I.K. (2008). Jet injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral

intravenous catheterization in children: A randomized controlled trial. Pediatric Emergency Care, 24, 511-515. doi:10.1097/PEC.0b013e31816a8d5b

A

S

StArcaJo

Gan

SE

In

1.

1.

1.

1.

1.

1.

1.

1.

Appendix 5

S I G N

Me

tudy identificrendts, G., Sannulation suournal of Ana

uideline topicn Emergency

ECTION 1:

n a well cond

1 The stuclearly

2 The asgroups

3 An adeused

4 Subjec‘blind’ a

5 The tresimilar

6 The onthe tre

7 All relestanda

8 What pclusterarm of

Methodolo

ethodologyC

cation (IncluStevens, M. &uccess in paeaesthesia, 10

c: The Use oy Departmen

INTERNAL

ducted RCT

udy addressy focused que

ssignment of s is randomis

equate conce

cts and invesabout treatm

eatment and r at the start o

nly differenceatment unde

evant outcomard, valid and

percentage ors recruited inf the study dr

ogical Qual

Checklist 2:

ude author, ti& Fry, M. (20ediatric patie00, 521-524.

of Topical Annt

L VALIDITY

T study…

es an appropestion.

f subjects to tsed

ealment met

stigators are ment allocatio

control grouof the trial

e between grer investigatio

mes are measd reliable way

of the individunto each trearopped out b

57

lity Appras

Controlled

itle, year of p08). Topical

ents: A randodoi:10.1093

esthesia to R

priate and

treatment

hod is

kept on

ups are

roups is on

sured in a y

uals or atment efore the

ial

Trials

publication, joanaesthesia

omized doub3/bja/aen003

Reduce Pedi

In this stud

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

Well covere

Adequately addressed

Poorly addre

EMLA Grou

AnGEL Gro

ournal title, pa and intravele-blind trial.

atric IV Cann

dy this criter

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

p=13/93 x 10

up=13/110 x

pages) nous British

nulation Pain

rion is:

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

00% = 13.98

x 100% =

n in

8%

58

study was completed? 11.82%

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

Comments: Drop-out rate > 10%. No true controls.

S

StAuofinsdo

Gan

In

1.

1.

1.

1.

1.

1.

1.

1.

S I G N

Me

tudy identificuerbach, M.,f jet lidocainesertion in theoi:10.1111/j.1

uideline topicn Emergency

SECTIO

n a well cond

1 The stuclearly

2 The asgroups

3 An adeused

4 Subjec‘blind’ a

5 The tresimilar

6 The onthe trea

7 All relestanda

8 What pclusterarm of study w

ethodologyC

cation (Inclu Tunik, M. &

e compared te emergency553-2712.20

c: The Use oy Departmen

N 1: INTER

ducted RCT

udy addressy focused que

ssignment of s is randomis

equate conce

cts and invesabout treatm

eatment and r at the start o

nly differenceatment unde

evant outcomard, valid and

percentage ors recruited inthe study dr

was complet

Checklist 2:

ude author, tiMojica, M. (

to jet placeboy department009.00401.x

of Topical Annt

RNAL VALID

T study…

es an appropestion.

f subjects to tsed

ealment met

stigators are ment allocatio

control grouof the trial

e between grer investigatio

mes are measd reliable way

of the individunto each trearopped out bed?

59

Controlled

itle, year of p2009). A rano for pain relt. Academic

esthesia to R

DITY

priate and

treatment

hod is

kept on

ups are

roups is on

sured in a y

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publication, jodomized, doief in childreEmergency M

Reduce Pedi

In this stud

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Poorly addre

Well covere

Adequately addressed

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Adequately addressed

Poorly addre

Well covere

Adequatelyaddressed

Poorly addre

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Adequately addressed

Poorly addre

No particip

ournal title, pouble-blind con undergoingMedicine, 16

atric IV Cann

dy this criter

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

d

y

essed

No

No

No

ed

essed

No

No

No

ed

essed

No

No

No

pants droppe

pages) ontrolled studg needle 6, 388-393.

nulation Pain

rion is:

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

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ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ot addressed

ot reported

ot applicable

ed out.

dy

n in

60

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

++

Comments: Patients in the jet placebo group were less likely to have a recent needle insertion compared to the jet lidocaine and jet control groups (p < 0.05). Jet to cannulation time may be too short to let lidocaine provide effect.

S

StCovach

Gan

In

1.

1.

1.

1.

1.

1.

1.

1.

S I G N

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tudy identificostello, M., Rapocoolant shildren. Clinic

uideline topicn Emergency

SECTIO

n a well cond

1 The stuclearly

2 The asgroups

3 An adeused

4 Subjec‘blind’ a

5 The tresimilar

6 The onthe tre

7 All relestanda

8 What pclusterarm of study w

ethodologyC

cation (IncluRamundo, Mpray fails to cal Pediatrics

c: The Use oy Departmen

N 1: INTER

ducted RCT

udy addressy focused que

ssignment of s is randomis

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nly differenceatment unde

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Checklist 2:

ude author, ti., Christophedecrease pas, 45, 628-63

of Topical Annt

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es an appropestion.

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of the individunto each trearopped out bed?

61

Controlled

itle, year of per, N.C. & Poain associate32. doi:10.11

esthesia to R

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(a)ethyl viny

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ournal title, p2006). Ethyl venous cannu

280629101

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No

No

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essed

No

No

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No

No

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ot addressed

ot reported

ot applicable

ot addressed

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1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

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Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

Comments: Not enough information about randomization was provided. No p-values in comparing demographic data. Drop-out rate of control group > 10%.

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ethodologyC

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Checklist 2:

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33(4), 395-3

of Topical Annt

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63

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study was completed?

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

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Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

-

Comments: Not enough information about concealment method and blinding were provided. The validity and reliability of the some scales were not mentioned. Only about 10% of eligible participants were able to be captured. No true controls. Sample size too small.

S

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Checklist 2:

ude author, tiootman, M. &

before perip17-e220

of Topical Annt

RNAL VALID

T study…

es an appropestion.

f subjects to tsed

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stigators are ment allocatio

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mes are measd reliable way

of the individunto each trearopped out bed?

65

Controlled

itle, year of p& Kennedy, Rpheral intrave

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No particip

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1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

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Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

++

Comments: An observer who did not know the purpose of study was used, making the investigation somehow blinded. Not enough information of intention to treat analysis. No p-values were provided for demographic data except prior experience of IV cannulation. No true controls.

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arm of the study dropped out before the study was completed?

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

-

Comments: Only abstract could be achieved. Much information was not mentioned in detailed. The study was not applicable to be blinded.

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Med J, 26, 487

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a children's 7-491. doi:10

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No

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No

No

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No

No

No

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No

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No

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1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

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Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

++

Comments: Drop-out rate was not systematically reported, <10%. 2 scales were used for different age groups. Some of the results (95% CI) were shown on graphs only. No true controls.

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epartment. Pe0006565-200

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of Topical Annt

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f subjects to tsed

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stigators are ment allocatio

control grouof the trial

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mes are measd reliable way

of the individunto each trearopped out bed?

71

Controlled

itle, year of pSutherland, Dntravenous c

ergency Care005

esthesia to R

DITY

priate and

treatment

hod is

kept on

ups are

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uals or atment efore the

Trials

publication, joD. (2001). Effcannula insere, 17, 341-34

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In this stud

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No particip

ournal title, pficacy of ethyrtion in a ped

43.

atric IV Cann

dy this criter

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y

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No

No

No

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No

No

No

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No

No

No

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No

No

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No

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No

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72

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

Comment: Not enough information of concealment method was provided. Writing style should be logical and systematic. Reporting p-value should be in numeric form instead of NS. No true controls.

S

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was complet

Checklist 2:

ude author, tiaani-Levinz, Hnesthetic withed controlled181a689ec

of Topical Annt

RNAL VALID

T study…

es an appropestion.

f subjects to tsed

ealment met

stigators are ment allocatio

control grouof the trial

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mes are measd reliable way

of the individunto each trearopped out bed?

73

Controlled

itle, year of pH., Shachor-h disinfectan trial. Clinica

esthesia to R

DITY

priate and

treatment

hod is

kept on

ups are

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uals or atment efore the

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publication, jo-Meyouhas, Ynt (LidoDin) val Journal of P

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ournal title, pY. & Kassis, versus EMLAPain, 25, 711

atric IV Cann

dy this criter

ed

essed

No

No

No

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No

No

No

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No

No

No

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No

No

No

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No

No

No

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No

No

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No

No

No

pants droppe

pages) I. (2009).

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74

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

Comments: No true controls. Sample size too small. Long-term side effects were not measured.

S

StSilidra

Gan

In

1.

1.

1.

1.

1.

1.

1.

1.

S I G N

Me

tudy identificnger, A.J., Ta

docaine/tetraandomized co

uideline topicn Emergency

SECTIO

n a well cond

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4 Subjec‘blind’ a

5 The tresimilar

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8 What pclusterarm of study w

ethodologyC

cation (Incluaira, B.R., Ccaine patch ontrolled trial

c: The Use oy Departmen

N 1: INTER

ducted RCT

udy addressy focused que

ssignment of s is randomis

equate conce

cts and invesabout treatm

eatment and r at the start o

nly differenceatment unde

evant outcomard, valid and

percentage ors recruited inf the study drwas complet

Checklist 2:

ude author, tihisena, E.N.versus placel. Ann Emerg

of Topical Annt

RNAL VALID

T study…

es an appropestion.

f subjects to tsed

ealment met

stigators are ment allocatio

control grouof the trial

e between grer investigatio

mes are measd reliable way

of the individunto each trearopped out bed?

75

Controlled

itle, year of p, Gupta, N. &

ebo before pg Med, 52(1)

esthesia to R

DITY

priate and

treatment

hod is

kept on

ups are

roups is on

sured in a y

uals or atment efore the

Trials

publication, jo& Chipley, J.ediatric intra), 41-47.

Reduce Pedi

In this stud

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Placebo gro13.04%

ournal title, p(2008). Warvenous cann

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No

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No

No

No

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No

No

No

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No

No

No

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No

No

No

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No

No

No

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No

No

No

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76

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

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78

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Well covered

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Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

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Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

+

Comments: Sample size too small. Although mean age of patient is high (over 18yrs), stratified randomization was used and data of pediatric subjects could be indepedently analyzed.

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Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

++

Comments: Sample size relatively small. Not enough demographic data was provided. No sham ultrasound device or true contol.

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82

1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.10 Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code ++, +, or

++

Comments: Race difference is significant. No true control.

83

Appendix 6

NTWC Pain Assessment Tool

FLACC Scale

84

Appendix 7 Material cost of J-Tip Injector innovation (per year)

Appendix 8 Material cost of Sonoprep innovation (per year)

Item Setup cost

****

Running cost ****

Sonoprep + Anesthetic cream +

procedure trays **

US$1,995 US$(200/50 + 8) x

1,565

Cannulation Materials (Tegaderm, IV

block, IV catheter, NS, syringe, etc.)

N/A US$4 x 1,565

Training (by Sonoprep agent) N/A N/A

Miscellaneous (for ink, briefing

notes, etc)

N/A US$200

Subtotal US$1,995

(HK$15,561)

US$25,240

(HK$196,872)

Total US$27,235

(HK$212,433)

Item Setup

cost ****

Running cost

****

J-Tip Injector * N/A US$2.1 x 1,565

Cannulation Materials (Tegaderm, IV

block, IV catheter, NS, syringe, etc.)

N/A US$4 x 1,565

Training (by J-Tip Injector agent) N/A N/A

Miscellaneous (for ink, briefing notes, etc) N/A US$200

Subtotal 0 US$9,746.5

(HK$76,022.7)

Total US$9,746.5

(HK$76,022.7)

85

Appendix 9 Material cost of Er:YAG Laser innovation (per year)

Item Setup cost **** Running cost

****

Er:YAG Laser + Anesthetic

cream ***

(550,000+630,000)/2

= 590,000 SEK

= US$85,659.74

US$200/50 x

1,565

Cannulation Materials

(Tegaderm, IV block, IV

catheter, NS, syringe, etc.)

**

N/A US$4 x 1,565

Training (by Er:YAG Laser

agent)

N/A N/A

Miscellaneous (for ink,

briefing notes, etc)

N/A US$200

Subtotal US$85,659.74

(HK$668,145.97)

US$12,720

(HK$99,216)

Total US$98,379.74

(HK$767,361.97)

* Cost of J-Tip Injector is quoted from Spanos et al (2008).

** Cost of Sonoprep, Anesthetic cream and procedure trays are quoted

from Australia and New Zealand Horizon Scanning Network (2005).

*** Cost of Er:YAG Laser is estimated from the mean of quotation price,

550 000–630 000 Swedish kronor (SEK), from Swedish Council on Health

Technology Assessment (2009), while US$1= 6.8877 SEK. Cost of

anesthetic cream is quoted from Australia and New Zealand Horizon

Scanning Network (2005).

**** US$1 = HK$7.8

86

Appendix 10 Staff Cost (Setup Cost)

Staff Type Monthly Salary

per person *

Working Hours Cost

Team Leader:

APN x1

HK$45,020 2hrs x 5 = 10hrs ** HK$1,875.8

Team Member:

RN x3

HK$29,087.5 (2hrs x 5 x 3) +

24hrs + 12hrs +

24hrs = 90hrs ***

HK$10,907.8

Total � � HK$12,783.6

* Quoted from medium salary point of APN and RN salary in Hospital

Authority Accounting Circular No. 10/2011

**5 2-hour-long meetings

***5 2-hour-long meetings, 24-hour-long guideline development,

12-hour-long audit and pilot evaluation and 24-hour-long data collection,

analysis and evaluation

Appendix 11 Estimated Cost of Innovation

Category Cost (HK$)

Staff Cost (Setup Cost) 12,783.6

Material and Equipment Cost (Running Cost) 76,022.7

Hidden Cost

– Cost of nurses administering anesthesia;

assessing pain level and adverse effects

Not estimated

– Venue of Training Sessions and

Meetings

Hospital Premises

– Computer and Software for Data

Analysis

A&E Provision

Total Estimated Cost 88,806.3

Appendix 12 Cost of Current Practice

Admission

Expenses (HK$)

Length of

stay (day)

Number of

admission

Total Cost

(HK$)

3,590 5 150 2,692,500

87

Appendix 13

Evidence-based Guideline for the Use of Topical Anesthesia in

Pediatric Intravenous Cannulation in Emergency Departments

Background

– Venipuncture is a common invasive procedure in emergency

departments (Bulechek, McCloskey, Titler & Denehey, 1994; Doniger,

Ishimine, Fox & Kanegaye, 2009).

– Venipuncture causes pain and distress in children (Costello, Ramundo,

Christopher & Powell, 2006; Singer & Richman, 1999).

– Pain is the 5th vital sign.

– Poor pain management can lead to unpleasant experience, interruption

of procedure and may increase healthcare cost (Cummings, Reid, Finley,

McGrath, & Ritchie, 1996; Hospital Authority, 2010; Singer & Richman,

1999).

– Current practice of anesthesia (local infiltration of lidocaine) also causes

pain (Armstrong, Young & Mckeown, 1990; Langham & Harrison,

1992; Selby & Bowles, 1995).

– Topical anesthesia can avoid injection pain and it is effective in

88

reducing pain in painful procedures (Barnett, 2009).

– No clinical protocol for anesthesia for pediatric venipuncture in the

emergency departments is available.

Target Population

– Children aged 5-18 years who need venipuncture

Target Settings

– An emergency department in Hong Kong

Aim

– To assist professionals to set up standardized needleless anesthesia

intervention for children who need venipuncture in emergency

departments

Objectives

– To summarize and synthesize the current evidence for anesthesia for

pediatric IV cannulation

– To formulate recommendations for innovation based on the best available

evidence

Guideline Development

– SIGN 50: A Guideline Developer's Handbook (Scottish Intercollegiate

Guideline Network (SIGN), 2011) as reference

89

– Research Question: What is the effectiveness and safety of topical

anesthesia (EMLA, ELA-Max and lidocaine gel, ethylchloride spray,

lidocaine/tetracaine patch and jet lidocaine) for intravenous cannulation

of pediatric patients in the emergency settings?

– Literature Review

Searching Strategies

Database

i. PubMed

ii. CINAHL

iii. Embase

Keywords

i. Topical anesthesi* OR Local anesthesi*, AND

ii. Vein catheterization OR Venous catheterization OR

Vascular access OR Venous access OR Venipuncture OR

Venepuncture OR cannulation OR needle insertion, AND

iii. Emergency department OR emergency service OR

emergency setting OR ED

Type of study: Randomized Controlled Trial (RCT)

Inclusion criteria

90

i. the target population were children from 5 to 18 years

of age;

ii. it was conducted in emergency settings; and

iii. intravenous cannulation was done with topical

anesthesia.

Exclusion criteria

i. only lidocaine infiltration was received; or

ii. it was not a randomized controlled trial.

Appraisal Strategies

Level of Evidence (SIGN, 2004)

Table 1 Level of Evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of

bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias

and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and

a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant

risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Search Results

13 RCTs

91

– Implementation Potential Assessment

Transferability

Feasibility

Cost-benefit Ratio

Recommendations

Recommendation is graded by SIGN 50: A guideline developer’s handbook.

(SIGN, 2011)

Table 2 Grade of Recommendation (SIGN, 2011)

Grade Statements

A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly

applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable

to the target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target

population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good practice

points

Recommended best practice based on the clinical experience of the guideline

development group

– Recommendation 1.0

Topical anesthesia and venipuncture can be performed by nurses.

92

(Grade of Recommendation: A)

Nurses are able to administer topical anesthesia and perform

intravenous insertion (Arendts, Stevens & Fry, 2008; Auerbach, Tunik

& Mojica, 2009; Costello et al., 2006; Newbury& Herd, 2009; Ramsook,

Kozinetz & Moro-Sutherland, 2001; Shavit, Hadash, Knaani-Levinz,

Shachor-Meyouhas & Kassis, 2009; Singer, Taira, Chisena, Gupta &

Chipley, 2008; Singer, Weeks & Regev, 2006; Skarbek-Borowska,

Becker, Lovgren, Bates & Minugh, 2006; Spanos, Booth, Koenig, Sikes,

Gracely& Kim, 2008) (1+, 1+, 1+, 1++, 1+, 1+, 1+, 1+, 1++, 1++).

– Recommendation 2.0

Anesthesia should be considered after comparing the benefits, like the

onset time and the effect, against the risks, like the side-effects and costs.

(Grade of Recommendation: A)

Known allergy to anesthetic agent, existing skin problem of the

venipuncture site and emergency conditions that require immediate

venipuncture should be considered as contraindication for anesthesia

(Arendts et al., 2008; Auerbach et al., 2009; Costello et al., 2006;

Luhmann, Hurt, Shootman & Kennedy, 2004; Ramsook et al., 2001;

Shavit et al., 2009; Singer et al., 2008; Singer et al., 2006;

93

Skarbek-Borowska et al., 2006; Spanos et al., 2008) (1+, 1+, 1+, 1++,

1+, 1+, 1+, 1+, 1++, 1++).

– Recommendation 3.0

Venipuncture site should be disinfected before anesthesia administration.

(Grade of Recommendation: A)

Venipuncture site should be cleansed (Ramsook et al., 2001) (1+) with

sterile technique (Costello et al., 2006) (1+). Alcohol would be the

choice of cleansing agent for the venipuncture site prior to anesthesia

(Auerbach et al., 2009;Singer et al., 2006) (1+, 1+).

– Recommendation 4.0

Smaller gauge of needle should be chosen for venipuncture. (Grade of

Recommendation: B)

Smaller gauge (21-24) of needle should be considered (Auerbach et al.,

2009; Costello et al., 2006; Luhmann et al., 2004; Newbury& Herd,

2009; Shavit et al., 2009; Singer et al., 2008; Singer et al., 2006;

Skarbek-Borowska et al., 2006; Spanos et al., 2008) (1+, 1+, 1++, 1++,

1+, 1+, 1+, 1++, 1++). It is consistent with the existing knowledge that

smaller gauge of needle produces less pain during needle insertion.

(Zempsky, 2008)

94

– Recommendation 5.0

Jet lidocaine injection is preferred for topical anesthesia for pediatric

venipuncture. (Grade of Recommendation: A)

A good choice of topical anesthesia in the emergency departments

should be effective, fast-reacting and inexpensive. Jet lidocaine

injection, ELA-Max cream with sonication and ELA-Max cream with

laser assistance provide fast and effective anesthesia. However, the

setup cost of sonication and the laser is high. In contrast, jet lidocaine is

inexpensive, providing a high level of cost-effectiveness (Auerbach et

al., 2009; Singer et al., 2006; Skarbek-Borowska et al., 2006; Spanos et

al., 2008) (1+, 1+, 1++, 1++).

– Recommendation 6.0

Venipuncture should be done at least 5 minutes after jet lidocaine

injection. (Grade of Recommendation: A)

Sufficient time should be given for the onset of anesthesia. Jet lidocaine

cannot provide adequate anesthetic effect in 1 minute. At least 5 minutes

is needed for drug onset (Auerbach et al., 2009;Spanos et al., 2008) (1+,

1++).

– Recommendation 7.0 Adverse Effects

95

Recommendation 7.1

Patients’ skin condition should be assessed by the Numerical Scales

for Skin Assessments (1) immediately after, and (2) 1 hour after

anesthesia administration for adverse effects. (Grade of

Recommendation: B)

Changes in skin may occur after topical anesthesia administration

(Newbury& Herd, 2009; Shavit et al., 2009; Singer et al., 2008;

Singer et al., 2006) (1++, 1+, 1+, 1+). Numerical Scales for Skin

Assessments (See Table 4), a 5-point rating scale, can be used as a

tool for adverse reactions 60 minutes after anesthesia

administration (Shavit et al., 2009) (1+). Skin assessment should be

done immediately after anesthesia (Skarbek-Borowska et al., 2006)

(1++). Follow up for adverse effects 1 week and 20-48 hours after

application was mentioned in the studies of Singer et al (2006) (1+)

and Skarbek-Borowska et al (2006) (1++) respectively, but it is not

practical for emergency departments.

96

Table 4 Numerical Scales for Skin Assessments

Score Erythema Edema Pruritus Hemorrhage/Petechiae

0 No erythema No edema No pruritus None

1

Very slight

erythema

(barely

perceptible)

Very slight

edema (barely

perceptible)

Occasional

pruritus

Isolated, up to 5 petechiae

2

Well-defined

erythema

Slight edema

(edges of area

well defined by

slight raising)

Constant

pruritus

Isolated but >5 petechiae

3

Moderate to

severe

erythema

Moderate

edema (raised

~1 mm)

NA Many, with some coalescence

4

Severe

erythema (beet

redness) to

slight eschar

formation

(injuries in

depth)

Severe edema

(raised >1 mm,

extending

beyond area of

exposure)

NA Numerous petechiae, with or

without pinprick spots of blood

on surface, or surface bleeding

irrespective of number of

petechiae

5 NA NA NA Frank bleeding

Recommendation 7.2

When adverse effects occur, the case should be reported to the

physician immediately. (Grade of Recommendation: Good practice

point)

Adverse reactions may be allergic reaction. Severe anaphylaxis

may cause death.

97

Biblography

Arendts, G., Stevens, M. & Fry, M. (2008). Topical anaesthesia and intravenous

cannulation success in paediatric patients: A randomized double-blind

trial. British Journal of Anaesthesia, 100, 521-524.

doi:10.1093/bja/aen003

Armstrong, P., Young, C. & Mckeown, D. (1990). Ethyl chloride and

venepuncture pain: A comparison with intradermal lidocaine. Can J

Anaesth, 37, 656–658.

Auerbach, M., Tunik, M. & Mojica, M. (2009). A randomized, double-blind

controlled study of jet lidocaine compared to jet placebo for pain relief

in children undergoing needle insertion in the emergency department.

Academic Emergency Medicine, 16, 388-393.

doi:10.1111/j.1553-2712.2009.00401.x

Barnett, P. (2009). Alternatives to Sedation for Painful Procedures. Pediatr Emer

Care, 25, 415 - 422.

Becker, B.M., Helfrich, S., Baker, E., Lovgren, K., Minugh, P.A. & Machan, J.T.

(2005). Ultrasound with topical anesthetic rapidly decreases pain of

intravenous cannulation. Academic Emergency Medicine, 12(4),

289-295.

98

Bulechek, G.M., McCloskey, J.C., Titler, M.G. & Denehey, J.A. (1994) Report on

the NIC Project. Nursing interventions used in practice. Am J Nurs, 94,

59–64,66.

Costello, M., Ramundo, M., Christopher, N.C. & Powell, K.R. (2006). Ethyl vinyl

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doi:10.1177/0009922806291013

Cummings, E.A., Reid, G.J., Finley, G.A., McGrath, P.J. & Ritchie, J.A. (1996).

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Doniger, S.J., Ishimine, P., Fox, J.C. & Kanegaye, J.T. (2009). Randomized

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Catheter Placement Versus Traditional Techniques in Difficult-Access

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10.1097/PEC.0b013e31819a8946

Hospital Authority. (2010). NTWC Policy on Pain Management. Retrieved

January 1, 2012, from

https://gateway.ha.org.hk/f5-w-687474703a2f2f746d682d747261696e

2d667330313a31363030$$/sites/NTWC_Document/policy_on_policy

/Cluster%20Policies/CS%20-%20Clinical%20Services/NTWC%20Po

99

licy%20on%20Pain%20Management.pdf

Kim, M.K., Kini, N.M., Troshynski, T.J. & Hennes, H.M. (1999). A randomized

clinical trial of dermal anesthesia by iontophoresis for peripheral

intravenous catheter placement in children. Ann Emerg Med, 33(4),

395-359.

Langham, B.T. & Harrison, D.A. (1992). Local anaesthesia: does it really reduce

the pain of insertion of all sizes of venous cannula? Anaesthesia, 47,

890–891.

Luhmann, J., Hurt, S., Shootman, M. & Kennedy, R. (2004). A comparison of

buffered lidocaine versus ELA-Max before peripheral intravenous

catheter insertions in children. Pediatrics, 113(3 Pt 1), e217-e220.

Mann, T., Taylor, D.McD. & Smit, P.D.V. (2007). Eutectic mixture of local

anaesthetics vs nitrous oxide for cannulation of children in the

emergency department. Journal of Pharmacy Practice and Research,

37(4), 281-283. Retrieved September, 2, 2011, from

http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=eme

d8&NEWS=N&AN=2008089643.

Newbury, C. & Herd, D.W. (2009). Amethocaine versus EMLA for successful

intravenous cannulation in a children's emergency department: a

100

randomised controlled study. Emerg Med J, 26, 487-491.

doi:10.1136/emj.2008.065110

Ramsook, C., Kozinetz, C.A. & Moro-Sutherland, D. (2001). Efficacy of ethyl

chloride as a local anesthetic for venipuncture and intravenous

cannula insertion in a pediatric emergency department. Pediatric

Emergency Care, 17, 341-343.

doi:10.1097/00006565-200110000-00005

Scottish Intercollegiate Guidelines Network. (2004). Methodology Checklist 2 :

Randomised Controlled Trials. Retrieved January 1, 2012, from

http://www.sign.ac.uk/guidelines/fulltext/50/checklist2.html

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Developer's Handbook. Retrieved January 1, 2012, from

http://www.sign.ac.uk/pdf/sign50.pdf

Selby, I.R. & Bowles, B.J. (1995). Analgesia for venous cannulation: a

comparison of EMLA, lidocaine, ethyl chloride and nothing. J R Soc

Med, 88, 264–267.

Shavit, I., Hadash, A., Knaani-Levinz, H., Shachor-Meyouhas, Y. & Kassis, I.

(2009). Lidocaine-based topical anesthetic with disinfectant (LidoDin)

versus EMLA for venipuncture: A randomized controlled trial.

101

Clinical Journal of Pain, 25, 711-714.

doi:10.1097/AJP.0b013e3181a689ec

Singer, A.J. & Richman, P.B. (1999). Comparison of patient and practitioner

assessment of pain from commonly performed emergency department

procedures. Ann Emerg Med, 33, 652-658.

Singer, A.J., Taira, B.R., Chisena, E.N., Gupta, N. & Chipley, J. (2008). Warm

lidocaine/tetracaine patch versus placebo before pediatric intravenous

cannulation: a randomized controlled trial. Ann Emerg Med, 52(1),

41-47.

Singer, A.J., Weeks, R. & Regev, R. (2006). Laser-assisted anesthesia reduces the

pain of venous cannulation in children and adults: a randomized

controlled trial. Academic Emergency Medicine,13(6), 623-628.

Skarbek-Borowska, S., Becker, B.M., Lovgren, K., Bates, A. & Minugh, P.A.

(2006). Brief focal ultrasound with topical anesthetic decreases the

pain of intravenous placement in children. Pediatric Emergency Care,

22, 339-345. doi:10.1097/01.pec.0000216566.33747.5b

Spanos, S., Booth, R., Koenig, H., Sikes, K., Gracely, E. & Kim, I.K. (2008). Jet

injection of 1% buffered lidocaine versus topical ELA-Max for

anesthesia before peripheral intravenous catheterization in children: A

102

randomized controlled trial. Pediatric Emergency Care, 24, 511-515.

doi:10.1097/PEC.0b013e31816a8d5b

Zempsky, W.T. (2008). Pharmacologic Approaches for Reducing Venous Access

Pain in Children. Pediatrics,122, Suppl 3, S140-S153. doi:

10.1542/peds.2008-1055g

103

Appendix 14 Gantt Chart of Implementation Plan

104

Appendix 15

Opinion for Pilot Test

Opinion for The Use of Topical Anesthesia to Reduce Paediatric Intravenous Cannulation Pain

Date Opinion/Comment

105

Gum Label

Appendix 16 Pediatric IV Cannulation Record

Pediatric IV Cannulation Record

Please Tick the appropriate Box.

For Others, please specify.

Ethnicity: □Asian □White □Black □Indian □Others:___________

Chief Complaint: □Abdominal pain □Dehydration □Orthopedic

□Infectious □Allergy □Others:____________

Size of Cannula: □20GA □22GA □24GA □Others:_______

Location of Cannulation: □Antecubital □Hand □Others:__________

Pain Score:____________/10

Adverse Events: □None □Erythema □Edema □Pruritus

□Others:__________

Disposal: □Home □EMW □Admission

P.T.O. for FLACC Scale

106

FLACC Scale

Please return to collection box in nursing station after completion.

107

Appendix 17 Evaluation Table

Outcomes Tools Frequency

(Wk)

Objectives Method of

Analysis

Basis of Change

Pain NTWC Pain Assessment Tool

(units)

26 To determine if pain is reduced compared to that of

non-intervention period

2-tailed

t-test*

Reduce 1 unit

Admission

rate

Patient record (%) 26 To determine if admission rate reduced compared to

that of same period of last year

2-tailed t-test Reduce 3%

Length of

stay

Patient record (patient-day) 26 To determine if length of hospital stay reduced

compared to that of same period of last year

2-tailed t-test Reduce 1

patient-day

Staff

satisfaction

5-point Likert scale 13, 26 To estimate the staff satisfaction during the

innovation

95% CI Mean score >3

Utilization

rate

Patient Record (%) 13, 26 To estimate the utilization rate 95% CI >70%

Cost Account record, Compensation

hour record (HKD)

26 To evaluate the cost of innovation N/A Around

HK$44405.1

*Minimum significant effect: 1 unit, SD: 3 unit, Effect size d: 0.9, Power: 0.8, Alpha: 0.05

Sample size estimated: 73

Estimated number of clients weekly: 1565/52 = 30

Expected time to achieve 73 clients: 3 weeks

108

Appendix 18

Satisfactory Survey for Healthcare Providers- The Use of Topical Anesthesia to Reduce Pediatric Intravenous Cannulation Pain in an Emergency Department Please circle your answer.

Strongly

Disagree

Disagree No

Comment

Agree Strongly

Agree

1. I think this innovation can reduce pediatric IV

cannulation pain. 1 2 3 4 5

2. I think this innovation do not place a burden to

healthcare providers. 1 2 3 4 5

3. I think I am competent in doing this anesthesia

procedure. 1 2 3 4 5

4. I feel comfortable in doing this anesthesia

procedure. 1 2 3 4 5

5. I support this innovation. 1 2 3 4 5

Please return to collection box in nursing station after completion.

109

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