ORIGINAL ARTICLE

Procedural pain in children: education and management.The approach of an Italian pediatric pain center

Chiara Po’ & Caterina Agosto & Maria I. Farina &

Igor Catalano & Filippo Coccato & Piera Lazzarin &

Franca Benini

Received: 2 November 2011 /Accepted: 7 February 2012 /Published online: 7 March 2012# Springer-Verlag 2012

Abstract Pain management should be warranted for allchildren in every situation. Italian legislation proposes amodel for pain assistance based on specialized tertiarycenters which provide direct clinical management forcomplex cases and assure continuous cooperation withhospitals and family pediatricians for managing painfulconditions every day. The Procedural Pain Service ofthe University of Padua Department of Pediatricsapplies such model for procedural pain management.We describe activities of Service since January 1, 2006on two levels: education and training for territorialservices and sedation–analgesia when required for inva-sive and painful procedures. Since 2006 to date, theService team produced an internal protocol for proceduralsedation, developed two master courses, and organized atraining program for procedural pain management in theterritorial context. Procedural sedation–analgesia serviceprovided overall 10,832 sedations to perform 14,264procedures for 3,815 patients, median age of 6 yearsold. The most frequently performed procedures werelumbar puncture and bone marrow aspiration, followedby gastroscopy and bronchoscopy. Most frequently adminis-tered drug combinations were local analgesia + intravenousmidazolam alone or midazolam and propofol or midazolamand propofol and ketamine; most frequently used non-pharmacological methods were distraction using cartoonsand bubbles.Minor adverse events were recorded in 281 cases(2.5%), the most common being desaturation (2.1%). In

conclusion, our model functions on two integrated levels,and it can be considered generally applicable as a solutionfor pain management.

Keywords Procedural pain . Pain management .

Sedation–analgesia . Pain unit . Adverse effects

Introduction

About 20 years have elapsed since pain was recognized asan undertreated and little known aspect of pediatric care[33]. Experiencing pain in childhood has been correlatedwith short- and long-term consequences: It could influencesensitivity to pain, cause psychopathological conditions, andreduce patients’ and parents’ treatment compliance [12, 16,22, 30]. A large number of children suffer from pain relatedto medical procedures. Repeated procedures warrant carefulpain management because the quality of prior experiencescorrelates with the anxiety and distress suffered duringsubsequent experiences [10, 37]. Conscious sedation is rec-ommended by the international guidelines for minimallyinvasive procedures, while sedation–analgesia is consideredas the best solution for more invasive, painful proceduresbecause it enables patients to tolerate them while maintain-ing an adequate cardiorespiratory function [3–5].

At our “Salus Pueri” Pediatric Department, a pediatrictertiary care center at Padua University Hospital, proceduralpain management has been assured since 2003 by a struc-tured team (the procedural pain service) run by the RegionalPediatric Pain and Palliative Care Center.

The procedural pain service has been organized to pro-vide sedation–analgesia for medical procedures and trainingon the territorial management of everyday procedural painin children.

C. Po’ : C. Agosto :M. I. Farina : I. Catalano : F. Coccato :P. Lazzarin : F. Benini (*)Pediatric Pain and Palliative Care Service,Department of Pediatrics, University of Padua,Padua, Italye-mail: benini@pediatria.unipd.it

Eur J Pediatr (2012) 171:1175–1183DOI 10.1007/s00431-012-1693-9

For the procedural pain aspect, this organization corre-sponds to the system proposed in the Italian legislation onpain treatment (Italian law Nr. 38, March 2010): specializedtertiary centers for the direct clinical management of com-plex cases, for educating and training healthcare providers,and for scientific research, which should assure continuouscooperation with hospitals and family pediatricians respon-sible for managing painful conditions every day [18].

Aim

The purpose of this study is a retrospective evaluationof the last 5 years of the procedural pain service’sactivities in procedural pain management and educationon two integrated levels.

Methods

Education and training

As part of the Regional Pediatric Pain and Palliative CareCenter, the procedural pain service team is involved in pre-clinical and clinical activities concerning procedural pain,including scientific research on pain assessment and man-agement in pediatrics, training for family pediatricians andhospital pediatricians, the production of recommendationson pain management, medical advice for hospital and familypediatricians, round-the-clock availability for emergencypain situations, and sedation–analgesia for procedural painprovided by the procedural pain service.

Sedation–analgesia

The service for sedation–analgesia functions as a pediatricpain unit [26]. The team has three specialist pediatricians(pediatric hospitalists with lengthy experience of working ina pediatric intensive care unit), one resident pediatrician,three nurses, and two psychologists; all of whom havereceived specific training as recommended in the interna-tional guidelines ((1) capable of rapidly identifying andtreating respiratory and cardiocirculatory complications,(2) a proficient command of the characteristics and pharma-cology of sedatives–analgesics, (3) capable of maintainingor establishing a patent airway, (4) capable of initiatingassisted ventilation when necessary) [28]. Resident pedia-tricians receive detailed training in the pharmacology ofhypnotic–analgesic agents, clinical and instrumental moni-toring, and resuscitation (pediatric advanced life support); apractical training period of at least 2 months is also required.The nurses on the service’s team had also been working fora long time in a pediatric intensive care unit, they had

received training in pediatric-based life support, and theyfollow a practical training with a senior nurse for at least2 months. The personnel devoted to sedation–analgesiaand monitoring are not the same as those involved inthe invasive procedure, during which at least one physicianand one nurse on the pain service team are dedicated entirelyto sedation–analgesia.

The procedural pain service is open from 8:00 a.m. to3:00 p.m. 5 days a week, and it guarantees proceduralsedation for all scheduled procedures.

Procedures are performed in a dedicated room, adequatelyequipped in accordance with the international guidelines[3, 4, 28, 29, 31]. There are aids and instrumentsavailable for non-pharmacological treatments (e.g., toys, video,and computer) and space enough for parents to stay near theirchild’s bed before and during the induction of sedation–anal-gesia and when the patient is woken. Nearby, there is anothersuitably equipped room devoted to patient monitoring after theprocedure and for managing any emergencies.

Sedation–analgesia is provided for about 20 differenttypes of invasive, painful, or annoying procedure (includinglumbar punctures, bone marrow aspirations and biopsies,intrathecal chemotherapy, tracheo-bronchoscopies, endos-copies, arthrocentesis, hepatic and renal biopsies, skin biop-sies, transesophageal echocardiographies, venous accesses,surgical medications, ophthalmological procedures, dentalsurgery, thoracentesis, paracentesis, pericardiocentesis, pH-metry, and intracranial pressure monitoring).

Pain management is practiced using a combination ofsedation–analgesia and non-pharmacological methods(Table 1), following recommendations contained in aninternal protocol (Fig. 1). Data on patients, procedure,drugs used, vital signs, and adverse effects are reportedon a Microsoft Access Support. Randomly, children’sand parents’ satisfaction is assessed over a fortnight of theService’s activity by means of a 0–10 visual analog scale (0 0very dissatisfied; 10 0 very satisfied). Satisfaction with thepainful procedure is also measured for the nurse and physicianperforming the procedure and for the procedural pain servicenurses, using a 0–5 visual analog scale (0 0 poor service, 5 0

very good service).

Retrospective review

We descriptively reported the procedural pain service’s ac-tivities during the period from January 1, 2006 to December31, 2010. A retrospective review of scheduled sedationanalgesia sessions was conducted for the same period.Data on patients, procedures, and drugs used were pro-cessed using Microsoft Excel and analyzed using descriptivestatistics. The staff, locations, organization, and drugsremained the same during the period considered.

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Results

Education and training

Since 2006, several Service’s activities have been devoted toprocedural pain.

Internal protocol for procedural sedation–analgesia

The internal protocol “Children submitted to painful procedureswith sedation–analgesia” was written for the Pediatric Depart-ment by the procedural pain service’s physicians and nursesand approved by the hospital’s general director. A revisedversion has been certified under a quality assurance service.

Table 1 Drugs and treatments used for procedural sedation-analgesia following our protocol

Sedative-hypnotic agents

Drug Dosages Use

Midazolam (benzodiazepine)

Anxiolytic, amnestic (anterogradeamnesia), hypnotic effects.

0.05–0.2 mg/kg IV (max 5 mg); onset:2–3 min; duration of action: 20–30 min

All procedures

Action on GABAA receptorsstimulating neuron inhibition

0.5–0.75 mg/kg orally (max 15 mg); onset:10–20 min

Propofol (IV lipid-based globalcentral nervous depressant)

Only IV; 0.5–3 mg/kg for induction; onset:30–60 s; Duration of action (after bolus):2–5 min

All procedures

Hypnotic, anesthetic, amnestic effects. 0.5–1 mg/kg for maintenance or1–5 mg/kg/h in continuous infusionAction on GABA receptors.

Analgesic agents

Drug Dosages Use

Ketamine-S (NMDA-receptor antagonist) 0.1–1 mg/kg IV; onset: 30–60 s; durationof action: 10–15 min

BMA and BMB, skin, kidney and liver biopsies,colonoscopies, arthrocentesis, surgicalproceduresDissociative anesthesia, analgesic

and hypnotic effects.1.5–3 mg/kg IM; onset: 2–10 min; durationof action: 40–50 min

Local analgesia

Drug Application Use

Lidocaine/prilocaine; Dermal anesthetic Eutectic mixture of equal quantities (byweight) of lidocaine and prilocaine (EMLA):cream application 60–90 min before

At the site of venous cannulation for allprocedures. At the site of needle insertion: PL,BMA, BMB, skin, liver and kidney biopsies,surgical procedures, arthrocentesis

Lidocaine infiltration; Local anesthetic Local injection/oral and nasal liquidinstillation for bronchoscopies(lidocaine 2% for nasal instillation;0.5–1% for tracheal instillation)

BMB, skin biopsies, surgical procedures.Nasal/oral liquid instillation forbronchoscopies

Non-pharmacological therapy

Type Application Use

Distraction “passive distraction”: singing, talking, blowingbubbles, juggling; “active distraction”: playing,painting, conversation

Before induction for all procedures

Cognitive-behavioral modeling, imagery, and relaxation Before induction especially for children≥6 yrs old

Hypnosis Treatment requiring skilled, trained personnel Before and during procedure whensedation/analgesia is contraindicated

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Fig. 1 Internal protocol for procedure management (PR procedure room)

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Training for family and local hospital pediatricians

A training program was implemented in 2010, designed forall family and hospital pediatricians in the Veneto Region(about 800 physicians). Eighty of these pediatricians wereinvited to attend a brief intensive course, where they wereable to provide conscious sedation for minimally invasiveprocedures using local anesthetics, non-pharmacologicalmethods, and low-dose benzodiazepines, and shared inter-vention recommendations were developed; each participantshould then teach ten colleagues belonging to their ownterritorial area/institution to use these recommendations.This program included an efficacy assessment (currentlyunderway) to be conducted a year after completing thecourse, considering several specific parameters (totalnumber of pediatricians trained, number of adequatesedation–analgesia sessions completed for painful proce-dures in randomly evaluated territorial hospitals, andnumber of times the procedural pain service was contactedby phone for specialist advice).

Master courses in pediatric pain and palliative careincluding procedural pain management

Two master’s courses on “Pediatric pain therapy and palli-ative care” were organized within the University of Padua,and an important part of these courses was dedicated toprocedural sedation–analgesia, including practical trainingat the procedural pain service. Each master’s course wasorganized for a maximum 15 visitors, and it accounted for1,500 h of teaching activities (1,200 h of stage and about300 h of frontal lessons). Among them, 200 h were devotedto procedural pain management in pediatrics.

Sedation–analgesia

From January 1, 2006 to December 31, 2010, the painservice was operational for 1,272 days, during which time

3,815 patients were scheduled for 10,832 sedations and14,264 procedures.

The number of procedures performed annually rangedfrom 2,477 to 3,059 (Table 2), with a mean of 8.5 proce-dures a day.

Patients referred to the procedural pain service

The patients had a median 6 years old (IQR 2–10); 38patients were more than 18 years old at the time of theprocedure. During the 5 years considered, 42.3% of thepatients were referred to the Service more than once;most of them underwent two or three procedures(63.7%), but 11–25 procedures were performed in11.9% of them, 26–40 procedures were performed in5.8%, and 16 patients underwent more than 41 procedures(maximum 61 procedures).

Most patients were classified as ASA 1 and 2, but 450patients were ASA 3, and 13 patients were classified asASA 4.

Procedures

The most frequently performed procedures were lumbarpuncture and bone marrow aspiration, followed by gastros-copy and bronchoscopy (Fig. 2).

More than one procedure was provided during the samesedation session in 27% of cases.

The median sedation time was 12:21 min (IQR 07:26–17:54). Colonoscopies and gastroscopies generallydemanded a longer sedation time than the other procedures(median 18 min).

Sedation–analgesia

The level of sedation was almost always described as “mod-erate to deep.” “Conscious sedation” was used in 526 cases(5.7%), mainly for lumbar punctures (47%) and bone marrow

Table 2 Number of proceduresperformed yearly by the proce-dural pain service for differentdepartments at the PaduaUniversity Pediatric Hospital

2006 2007 2008 2009 2010 Total Percent

Pediatrics unit—outpatients 433 448 444 383 432 2,140 15.0%

Pediatrics unit—inpatients 648 638 706 534 643 3,169 22.2%

Pediatric intensive care unit 43 33 40 7 3 126 0.9%

Pediatric emergency unit 59 67 83 52 67 328 2.3%

Pediatric oncology unit—outpatients 1,124 1,090 883 964 1,192 5,253 36.8%

Pediatric hematology-oncologyunit—inpatients

655 640 551 510 695 3,051 21.4%

Pediatric hospice 2 15 17 24 58 0.4%

Others 38 42 24 20 15 139 1.0%

Total procedures per year 3,000 2,960 2,746 2,487 3,071 14,264

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aspirations (35.5%); the median age of these patients was6.2 years old (IQR 3.5–11.1 years old).

Non-pharmacological treatments were used before theinduction of the sedation–analgesia for all the sedationsand were tailored to the patient’s preference. More frequentlyused methods were distraction by cartoons (about 40% ofsedations, mean age 6.7 years, IQR 4.4–9.8) and bubbles(about 30% of sedations, mean age 3.4 years, IQR 1.9–5.9).Psychological techniques such as biofeedback, hypnosis, andimagery were used for less than 1% of the sedations, mean age12.4 (IQR 9.1–13.8).

EMLA cream was applied in 6,278 venous cannulationprocedures (i.e., for all patients needing a venous cannula-tion). It was also applied at the site of 9,644 other procedures,

including all lumbar punctures, bone marrow aspirations andbiopsies, for arthrocentesis, and for skin, kidney, and liverbiopsies. Local lidocaine infiltration was used for 1,274 pro-cedures (bone marrow biopsies, kidney and skin biopsies, andsurgical procedures), and oral lidocaine instillation was usedfor 690 procedures (bronchoscopies).

The most often used combinations were intravenous mid-azolam + propofol or midazolam + ketamine + propofol.The drugs used were accurately recorded for 8,730 sedations(Table 3).

Adverse events

Among a total of 10,832 sedation sessions, none of thepatients required intubation or cardiorespiratory rescue oradmission to intensive care, and there were no complica-tions resulting in long-term morbidity or mortality.

Minor adverse events were recorded in 281 cases (2.5%).The reported effects were desaturation (233), laryngo-

spasm (17), bronchospasm (12), vomiting (5), hypotension(4), agitation (3), bradycardia (2), hypersalivation (1), andseizures (1).

Of the procedures, 23 were stopped (0.2%), mainly bron-choscopy and gastroscopy, because of laryngospasm (17episodes) or bronchospasm (5), with immediate recoveryin the procedure room administering aerosol therapy. Themost common adverse effect was desaturation (82.9%), witha reported oxygen saturation ≤92%. Desaturation occurredmainly during bronchoscopy (42%) and gastroscopy (12%).

Fig. 2 Procedures handled by the procedural pain service from 2006to 2010

Table 3 Drug combinations used depending on the type of the more frequently performed procedures (8,730 sedation sessions)

Midazolam Ketamine Propofol Midazolamketamine

Midazolampropofol

Propofolketamine

Midazolamketamine propofol

Total

Arthrocentesis 112 4 2 19 2 4 247 390

Liver biopsy 58 2 1 14 3 3 82 163

Kidney biopsy 71 1 2 16 2 9 123 224

Bronchoscopy 259 0 36 2 374 10 9 690

Gastroscopy 315 0 47 2 552 5 27 948

Colonoscopy 45 2 2 8 10 4 77 148

Dermatological procedure 33 2 2 2 1 2 47 89

Ophthalmological procedure 41 1 16 6 66 5 22 157

LP 1,070 20 51 125 828 34 762 2,890

BMA 642 8 32 153 25 17 862 1,739

LP + BMA 287 9 12 45 13 6 391 763

BMB 83 13 2 2 99 199

LP + BMA + BMB 3 2 12 148 165

Transesophagealechocardiography

48 8 1 106 1 1 165

Total 3,067 49 213 406 1,957 114 2,766 8,730

LP lumbar puncture, BMA bone marrow aspiration, BMB bone marrow biopsy

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Oxygen saturation ≤88% was reported in 35 episodes(≤85% in 17 of them). Bag mask ventilation was neededin 38 cases (16.3% of all desaturation episodes).

Among the patients classified as ASA 3, only 11 (2.4%)experienced adverse effects. Only one of the 13 patientsclassified as ASA 4 experienced a self-limiting hypotensionduring a lumbar puncture.

Satisfaction with the procedural pain service

In the latest satisfaction assessment conducted in January2010, the children (n023) undergoing painful proceduresrated their satisfaction at a mean of 8.6 (SD 2), and theirparents (n035) scored 9.3 (SD 0.9).

As for the Service’s staff, 95% of physicians and 98% ofnurses indicated a “good” or “very good” level of satisfac-tion with the procedure they assisted (4 or 5 on the 0–5scale). No statistically significant differences emergedbetween the satisfaction expressed by the nurses performingthe painful procedure and the procedural pain service’s nursesdedicated to sedation–analgesia, assistance, and monitoring.

Discussion

The importance of the training provided by a specializedtertiary care center is in tailoring the resources and methodsto different levels of complexity of pain control. The train-ing provided by our procedural pain service for family andhospital pediatricians is currently undergoing a careful effi-cacy assessment based on various indicators. For the timebeing, there are signs of a strong interest in our trainingcourses, and this is enabling the widespread diffusion ofmore information on procedural pain, which is a necessarypremise for its treatment on a large scale.

A safe, effective, and practical organization should beimplemented through the production of written recommen-dations [35]. In our experience, preparing and approving aninternal protocol enabled us to provide a safe and effectiveservice for the management of painful and invasiveprocedures.

Adherence to the international guidelines

Our pain service complies with the international guidelines[3, 4, 29] on pre-procedural evaluation, procedure roomequipment, patient preparation, drug administration, moni-toring, and discharge. The handling of all of these aspectshas been the object of a widespread consensus in the scien-tific community [15, 23, 28, 31], whereas certain otherissues are still controversial [17].

First, there is the question of the need to administer oxygenduring sedation–analgesia. In some experiences, supplemental

oxygen was administered throughout the procedure to reduceepisodes of desaturation, described as the most commonadverse effect of pediatric procedural sedation [5]. Otherauthors advise against this practice, however, becauseadministering oxygen could delay the identification ofapnea during peripheral oxygen saturation monitoring[20]. We avoid any routine use of supplemental oxygen,though it is always available for dealing with prolongeddesaturation episodes.

Second, the use of capnography is debated. The interna-tional guidelines encourage its use because it may enable therapid identification of hypoventilation; it should consequentlybe considered particularly for deep sedation or whenthere are limited means for assessing the adequacy ofventilation. Its use is not considered compulsory, how-ever [3, 4, 11]. Since we are able to observe the patientcontinuously and directly and we can always assess breathingsounds by auscultation during any type of procedure, weprefer not to use capnography.

Third, there is the matter of pre-procedural fasting.Pulmonary aspiration of gastric content is a potentiallysevere adverse event during sedation due to loss of theprotective airway reflexes. The ASA and AAP guide-lines contain the “Nil Per Os Recommendations” forelective procedures and suggest revising the target levelof sedation in the case of recent food intake in emergencysituations [3, 4, 11]. Recent studies conducted by emergencydepartments have discussed the period of fasting needed forsedation in emergency situations [1, 32, 36]. For the timebeing, we continue to follow the NPO recommendations.

Personnel preparation

In many countries, the problem of work overload in theanesthesia services [21] has been solved by training non-anesthetists to provide sedation–analgesia for procedural pain[28, 29, 35], e.g., emergency medicine specialists, gastroen-terologists, hospitalists, and critical care specialists [14, 17].Methods for teaching non-anesthesiologist pediatricians tomanage sedation–analgesia have been discussed in the inter-national literature [6, 24, 27, 34]. Our model includes bothfrontal education and experience-based training.

Safety

Our data on adverse events demonstrate that our serviceprovides a safe sedation–analgesia. The adverse event ratesreported in other experiences range from 2.44% [21] to 12%[26] and 17.9% [35]. Notwithstanding the non-standardizedterminology and definitions [9], the adverse effect mostcommonly reported in the literature is transient hypoxemia;no permanent adverse outcomes were described, and therates of severe adverse events were very low. Our

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experience confirms these findings, in that we had no severeevents, and among the 2.5% of adverse events recorded,desaturation accounted for more than 80% of cases; in mostcases (85%), this was transient, and oxygen saturationremained >88%.

On the contrary, cases of death, persistent neurologicaldamage, and a high percentage of severe adverse eventswere reported in the case of organizational inadequacies orfailure to comply with the international guidelines [13]. OurService’s experience confirms that accurate training andstrict compliance with the international guidelines are need-ed to avoid risks for patients.

Applicability and efficacy

Our model for procedural pain control meets all of the needsof the pediatric department, enabling about 20 differenttypes of painful, unpleasant procedure to be performed atthe hospital in both in- and outpatients. About 58% of theprocedures considered in this review were requested by thepediatric hematology–oncology unit, which explains thehigh rate of repeated procedures for the same patient (evenmore than 40 per patient). A sizable proportion of theprocedures assisted by our Service was endoscopies.Children with cancer often report that repeated diagnos-tic–therapeutic procedures were the most painful experi-ences relating to their malignancy [38], while endoscopies—though not particularly painful—are very distressing forchildren and often have to be repeated during a patient’sfollow-up. Being able to address and manage pain anddistress during such procedures therefore has a greatimpact on the patient’s and family’s quality of life andcan improve their treatment compliance.

Moreover, sedation outside the operating room reducesthe related social and economic costs compared with generalanesthesia [19], as well as enabling the use of a morecomfortable environment, with the parents attending to theirchild, and faster recovery times, which is why children andparents preferred it to general anesthesia [7, 8, 19, 25]. Themeasurement of patients’ and families’ satisfaction withprocedures assisted by our pain service demonstrated a highlevel of appreciation [8].

Conclusions

The experience gained by our procedural pain service at theUniversity of Padua’s pediatric department is an example ofthe application of a health care system as required by Italianlegislation, functioning on two integrated levels.

First, we provide specialized assistance with sedation–analgesia according to a clearly defined internal protocolthat ensures safe and effective procedural pain control for all

the needs encountered at the pediatric department. Thisservice has many benefits: Sedation–analgesia is proposedfor a large number of patients, including children withchronic conditions repeatedly needing painful procedures[38], procedures are performed outside the operating room[19], and therapy for procedural pain is tailored to eachpatient and includes a multimodal approach [2]. There isroom for improvement relating to the need to record painscores during and after a procedure; so far, pain has usuallybeen scored, but the score has not been recorded on theMicrosoft Access Support. The organization described hererequires dedicated, trained staff and appropriate spaces,which means that it has a marked financial impact, so itcan probably only be adopted at tertiary care centers.

Second, we organize training events for other pediatri-cians and health care operators working in the area to extendthe use of appropriate procedural pain control measures.

Conflict of interest The authors have no financial support or conflictof interest to disclose relating to this article.

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