2015 nsw health paediatric standards v2

27
Guideline Ministry of Health, NSW 73 Miller Street North Sydney NSW 2060 Locked Mail Bag 961 North Sydney NSW 2059 Telephone (02) 9391 9000 Fax (02) 9391 9101 http://www.health.nsw.gov.au/policies/ space space Standards for Paediatric Intravenous Fluids: NSW Health (second edition) space Document Number GL2015_008 Publication date 31-Aug-2015 Functional Sub group Clinical/ Patient Services - Medical Treatment Clinical/ Patient Services - Baby and child Summary The Standards address the appropriate choice of IV fluids and measures related to their procurement, storage and safe administration. The key changes in the second edition of the Standards regarding the content of IV fluids for children and neonates include: incorporating further evidence supporting the use of isotonic saline solutions in IV maintenance therapy; standardising the use of 1000mL bags in the care of children beyond the specialist children's hospitals; and incorporating Special Care Nursery practice and clarification around IV fluids for neonates. Replaces Doc. No. Standards for Paediatric Intravenous Fluids: NSW Health [GL2014_009] Author Branch NSW Kids and Families Branch contact NSW Kids and Families 02 9424 5978 Applies to Local Health Districts, Specialty Network Governed Statutory Health Corporations, Public Hospitals Audience All medical and nursing staff and pharmacy and procurement staff Distributed to Public Health System, Divisions of General Practice, NSW Ambulance Service, Ministry of Health, Private Hospitals and Day Procedure Centres, Tertiary Education Institutes Review date 31-Aug-2020 Policy Manual Not applicable File No. H15/18617 Status Active Director-General

Upload: mandy-crowley

Post on 16-Apr-2017

101 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: 2015 NSW Health Paediatric Standards V2

Guideline

Ministry of Health, NSW73 Miller Street North Sydney NSW 2060

Locked Mail Bag 961 North Sydney NSW 2059Telephone (02) 9391 9000 Fax (02) 9391 9101

http://www.health.nsw.gov.au/policies/

spacespace

Standards for Paediatric Intravenous Fluids: NSW Health (secondedition)

space

Document Number GL2015_008

Publication date 31-Aug-2015

Functional Sub group Clinical/ Patient Services - Medical TreatmentClinical/ Patient Services - Baby and child

Summary The Standards address the appropriate choice of IV fluids and measuresrelated to their procurement, storage and safe administration. The keychanges in the second edition of the Standards regarding the content ofIV fluids for children and neonates include: incorporating further evidencesupporting the use of isotonic saline solutions in IV maintenance therapy;standardising the use of 1000mL bags in the care of children beyond thespecialist children's hospitals; and incorporating Special Care Nurserypractice and clarification around IV fluids for neonates.

Replaces Doc. No. Standards for Paediatric Intravenous Fluids: NSW Health [GL2014_009]

Author Branch NSW Kids and Families

Branch contact NSW Kids and Families 02 9424 5978

Applies to Local Health Districts, Specialty Network Governed Statutory HealthCorporations, Public Hospitals

Audience All medical and nursing staff and pharmacy and procurement staff

Distributed to Public Health System, Divisions of General Practice, NSW AmbulanceService, Ministry of Health, Private Hospitals and Day Procedure Centres,Tertiary Education Institutes

Review date 31-Aug-2020

Policy Manual Not applicable

File No. H15/18617

Status Active

Director-General

Page 2: 2015 NSW Health Paediatric Standards V2

GUIDELINE SUMMARY

STANDARDS FOR PAEDIATRIC IV FLUIDS: NSW HEALTH

PURPOSE Intravenous fluids are important components of appropriate care for hospitalised children. Reports in the medical literature and warnings issued in other countries have highlighted the risks associated with use of low sodium content fluids. The importance of appropriate glucose content has also been identified.

The NSW Chief Paediatrician was tasked to engage clinical experts, HealthShare and a range of other partners in the development of state wide standards across all NSW facilities. The resulting Standards for Paediatric IV Fluids: NSW Health addresses fluid content, bag size, labelling, administration, procurement and storage.

Emerging new evidence and clinical experience motivated an early revision of the Standards, resulting in this second edition.

KEY PRINCIPLES The intended outcomes of the first edition of the standards regarding the content of IV fluids in children and neonates included:

• Reducing the risk of hyponatremia through increased sodium content and limiting the use of low sodium containing fluids

• Addressing glucose requirements of children and neonates through increased glucose content

• Consistent inclusion of potassium chloride as early as considered safe and appropriate.

The key changes in the second edition of the Standards regarding the content of IV fluids for children and neonates include:

• Incorporating further evidence supporting the use of isotonic saline solutions in IV maintenance therapy

• Standardising the use of 1000mL bags in the care of children beyond the specialist children’s hospitals

• Incorporating Special Care Nursery practice and clarification around IV fluids for neonates

The Statement of the Standards for Paediatric Intravenous Fluids: NSW Health (page 8) provides a summary of the recommended standards.

GL2015_008 Issue date: August-2015 Page 1 of 2

Page 3: 2015 NSW Health Paediatric Standards V2

GUIDELINE SUMMARY

USE OF THE GUIDELINE The following priorities have been identified to facilitate the implementation of Standards for Paediatric Intravenous Fluids: NSW Health (second edition) into all relevant clinical areas; Communication, Education and Raising Awareness, Integration into Practice, Procurement and Monitoring.

REVISION HISTORY Version Approved by Amendment notes August 2015 (GL2015_008)

Deputy Secretary, Population and Public Health

Further evidence supporting the use of isotonic saline solutions in IV maintenance therapy in paediatrics.

June 2014 (GL2014_009)

Deputy Secretary, Population and Public Health

New evidence

ATTACHMENTS 1. Standards for Paediatric Intravenous Fluids: NSW Health (second edition)

GL2015_008 Issue date: August-2015 Page 2 of 2

Page 4: 2015 NSW Health Paediatric Standards V2

L2014_XXX Issue date: August 2014

Revision due: August 2019 Page 2 of 30

Issue date: August 2015 GL2015_008

Standards for

PAEDIATRIC IV FLUIDS Second Edition

GUIDELINE

+

Page 5: 2015 NSW Health Paediatric Standards V2

L2014_XXX Issue date: August 2014

Revision due: August 2019 Page 2 of 30

NSW Kids and Families 73 Miller Street NORTH SYDNEY NSW 2060 Tel. (02) 9391 9000 Fax. (02) 9391 9101

http://www.kidsfamilies.health.nsw.gov.au

This work is copyright. It may be reproduced in whole or part for study or training purposes subject to the inclusion of an acknowledgement of the source. It may not be reproduced for commercial usage or sale. Reproduction for purposes other than those indicated above requires written permission from NSW Kids and Families. © NSW Health 2015 SHPN: (NKF) 150412 ISBN is 978-1-76000-241-1(Print), 978-1-76000-242-8(Online)

Further copies of this document can be downloaded from www.kidsfamilies.health.nsw.gov.au

August 2015 A revision of this document is due in 2020

Page 6: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Contents Page

Standards for Paediatric IV Fluids: NSW Health (second edition)

CONTENTS

1. EXECUTIVE SUMMARY ................................................................................................... 1

2. INTRODUCTION ............................................................................................................... 2

3. FLUID CONTENT: INTENDED OUTCOMES .................................................................... 2

4. LABELLING ...................................................................................................................... 3

5. FLUID BAG SIZE AND INTRAVENOUS FLUID THERAPY ADMINISTRATION .............. 3

6. SAFETY ............................................................................................................................ 4

6.1. Additional Measures For Low Sodium Content Products .......................................... 4

6.2. Plasma-Lyte 148 ....................................................................................................... 4

7. DEVELOPMENT OF THE STANDARDS AND THE HEALTHSHARE NSW CONTRACT....................................................................................................................... 4

8. SYSTEM-WIDE ENGAGEMENT ....................................................................................... 5

9. RELATIONSHIP WITH NATIONAL INTERIM GUIDELINES ............................................. 5

10. SUMMARY STATEMENT OF STANDARDS FOR PAEDIATRIC INTRAVENOUS FLUIDS (Second Edition) ................................................................................................. 6

11. TABLE OF PAEDIATRIC INTRAVENOUS SOLUTIONS (Fluids incorporated in the Summary Statement of Standards for Paediatric IV Fluids: NSW Health) ................... 7

12. APPENDICES ................................................................................................................... 8

12.1. Appendix 1 – Standards For Paediatric IV Fluids: NSW Health Working Group And Implementation Taskforce Membership ............................................................. 8

12.2. APPENDIX 2 - Consultation Undertaken Formally With Relevant Organisations In Developing The Standards For Paediatric IV Fluids: NSW Health (First Edition)..... 12

12.3. APPENDIX 3 – Labelling Practice ........................................................................... 13

12.4. APPENDIX 4 – Summary Table Of Stages In Development Of The Standards For Paediatric IV Fluids ................................................................................................. 17

12.5. APPENDIX 5 – References..................................................................................... 18

Page 7: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 1 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

1. EXECUTIVE SUMMARY

Intravenous fluids are important components of appropriate care for hospitalised children.

Reports in the medical literature and warnings issued in other countries have highlighted

the risks associated with use of low sodium content fluids. The importance of appropriate

glucose content has also been identified, and some evidence suggests risks associated

with high chloride in particular circumstances.

Individual or facility based responses to the changing literature, along with the interim

recommendations of a national expert group convened under the auspices of Children’s

Healthcare Australasia (CHA), had led to variable practices across NSW Health hospitals

with consequent inconsistencies and risks. The NSW Chief Paediatrician was tasked to

engage clinical experts, HealthShare NSW and a range of other partners in the

development of statewide standards across all NSW facilities. The resultant Standards for

Paediatric IV Fluids: NSW Health (first edition) addressed fluid content, bag size, labelling,

administration, procurement and storage.

The intended outcomes of the Standards (first edition) regarding the content of IV fluids in

children and neonates included:

Reducing the risk of hyponatraemia through increased sodium content and limiting

the use of low sodium containing fluids

Addressing glucose requirements of children and neonates through increased glucose content

Consistent inclusion of potassium chloride as early as considered safe and appropriate.

Following the introduction of the first edition of the Standards, clinician expert feedback, clinical incident reviews and product usage were closely monitored. Emerging new evidence confirmed the safety and efficacy of the use of isotonic solutions for intravenous fluid maintenance therapy in infants and children. The consequent early revision of the Standards has led to a second edition.

While at the time of the publication of the first edition consensus was readily reached for

recommendations regarding fluid content across NSW, the proposed size of paediatric

fluid bags (500mL v 1000mL) was left to the discretion of Local Health Districts (LHDs)

and Speciality Health Networks (SHNs). The fluid types and volumes purchased following

the introduction of the Standards across the State were monitored and further discussions

followed. In the second edition consensus was reached by clinicians with regard to

paediatric fluid bag sizes of 1000mL. The safety concerns associated with the larger bags

for children were alleviated by the widespread and consistent use of IV pumps and inline

burettes. For neonates, 500mL bags (or less) continue to be recommended.

The key changes in the second edition of the Standards for Paediatric IV Fluids include:

Incorporating further evidence supporting the use of isotonic saline solutions in IV

maintenance therapy

Standardising the use of 1000mL bags in the care of children, beyond the specialist

children’s hospitals

Incorporating Special Care Nursery practice and clarification of neonatal IV fluids

A succinct Summary Statement of the Standards presents the key messages and

related actions on a single page.

Page 8: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 2 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

2. INTRODUCTION

Intravenous (IV) fluids are frequently used in hospitalised children, predominantly to

maintain hydration and haemodynamic stability as well as for glucose replacement.

Historically, low sodium content fluids have been used for both maintenance and deficit

replacement. However, burgeoning medical literature has highlighted the risk of

hyponatraemia with their use and the particular dangers of fluids with extremely low

sodium content1-9,15,16,18. A number of countries have issued warnings against this practice10-

12. Increasingly, the published information1-12 supports the use of higher sodium content

isotonic fluids to prevent hyponatraemia10,16,18, as well as the need for adequate glucose

delivery to prevent hypoglycaemia6. Studies in critically ill adult patients13, as well as in

children15, have also suggested a preference for balanced salt solutions, as exemplified by

Plasma-Lyte148, to address risk of hyperchloraemia. As evidence continues to emerge

and best practice evolves, clinician discretion, informed by appropriate clinical and

laboratory data, is vital in all situations.

In response to the growing literature and in recognition of adverse events, clinicians

undertook to supplement existing manufactured fluids within paediatric facilities. This

practice introduced considerable risk of both dosing error and infection. A national expert

group was convened under the auspices of CHA and interim guidelines were developed

recommending appropriate fluid content. Commencing in 2010, the recommendations

were adopted by the Children’s Hospitals in NSW, who are members of CHA. They added

a further change to exclusively utilise the 1000mL bag size in order to improve both quality

and efficiency. Traditionally, 500mL bags have been used for children and neonates in

NSW, a distinguishing feature from adult practice. The resultant disconnect between the

Children’s Hospitals and other facilities highlighted the importance of standardisation of IV

fluids across all NSW services. The risks and confusion were compounded by the regular

rotations of junior medical staff and other workforce mobility as well as the very frequent

movement of patients between secondary and tertiary paediatric facilities. By the time of

the second edition of the Standards, the practice of 1000mL bags in paediatrics had

begun to extend beyond the Children’s Hospitals.

3. FLUID CONTENT: INTENDED OUTCOMES

The intended outcomes of the Standards (first edition) regarding the content of IV fluids in

children and neonates included:

Reducing the risk of hyponatraemia through increased sodium content and limiting

the use of low sodium containing fluids

Addressing glucose requirements of children and neonates through increased

glucose content

Consistent inclusion of potassium chloride as early as considered safe and

appropriate

The key changes in the second edition of the Standards regarding the content of IV fluids for children and neonates include:

Incorporating further evidence supporting the use of isotonic saline solutions in IV

maintenance therapy

Page 9: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 3 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

Standardising the use of 1000mL bags in the care of children, beyond the specialist

children’s hospitals

Incorporating Special Care Nursery practice and clarification of neonatal IV fluids

4. LABELLING

Subsequent to the tendering process and contractual agreements completed by

HealthShare NSW, further consultation with the contracted manufacturers, Baxter

Healthcare Australia, was undertaken. This led to revisions of bag labelling practice with

substantial clarification and improvement. The important messages and changes in

labelling are highlighted in the Summary Statement of Standards and in Appendix 3.

The National Recommendations for User-applied Labelling of Injectable Medicines, Fluids

and Lines (Labelling Recommendations) aim to enhance patient safety with clear,

practical labelling and identify, what should be labelled, what should be included on the

label and where the label should be placed. The Labelling recommendations refer to user

(clinician) applied labels. All paediatric and neonatal intravenous fluids are to be labelled

as per the Labelling Recommendations17,19.

5. FLUID BAG SIZE AND INTRAVENOUS FLUID THERAPY ADMINISTRATION

While consensus on fluid content across NSW was readily reached for the first edition of

the standards, the proposed size of the fluid bag (500mL v 1000mL) was more

contentious. The fluid types and volumes purchased following the introduction of the first

edition of the Standards across the State were monitored and movement towards 1000mL

bags was noted. The previous challenges to reach consensus to standardise fluid bag

sizes for children have been alleviated, as safety concerns have been addressed by the

widespread availability and consistent use of IV pumps and inline burettes for paediatric

IV fluid therapy. In the second edition consensus on paediatric fluid bag sizes was reached

by clinicians with 1000mL bags for use in children being consistently recommended.

This recommendation supersedes the prior Policy Directive PD2010_034, Section 3.3.11

mandate of 500mL bag size for all paediatric use. For neonates 500mL bags (or less)

continue to be recommended.

In accordance with NSW Health Policy Directive PD2010_034, Section 3.3.10: “Paediatric

infusion sets with an inline burette must be used for all children requiring intravenous

therapy. An infusion pump should be used in all children”. These aspects of the Policy

Directive are maintained and strongly reinforced. Current settings where variations of this

policy are recognised include Ambulance Service of NSW, operating theatres and acute

resuscitation scenarios. For the safety of paediatric and neonatal patients, the use of both

infusion pumps AND inline burettes is strongly recommended with all maintenance

and replacement fluids.

Fluids should be administered with the same caution that is used with any intravenous

drug, taking into consideration, the type, dose, indications, contraindications, potential for

toxicity, and cost13. IV fluids containing potassium chloride are potentially hazardous and

should be administered with extreme caution. Hourly observations of the IV fluids being

administered and IV cannula site should be documented on the NSW paediatric fluid

balance chart.

Page 10: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 4 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

6. SAFETY

6.1. ADDITIONAL MEASURES FOR LOW SODIUM CONTENT PRODUCTS

An important development in the NSW Standards is deliberately restricting access to

extremely low sodium content products, such as 0.225%, 0.22% and 0.18% sodium

chloride. A 0.22(5)% sodium chloride product will continue to be used in neonatal practice

with 10% glucose. Accordingly, LHDs/ SHNs are being asked to ensure that such products

be stored only in dedicated maternity/neonatal storage unit. Since adult practice may also

include such products, it is proposed that discussions take place, informed by the broader

literature, to explore their potential future alignment with paediatric initiatives. In the

meantime, the manufacturers will take steps to ensure that the labels of any such

products include a warning regarding low sodium content.

6.2. PLASMA-LYTE 148

The Standards acknowledge the emerging evidence for the use of balanced salt solutions,

in particular, Plasma-Lyte 14813,15. This option is incorporated in the revised Standards as

an alternative for both maintenance and rehydration, but only under the direction of a

Specialist. The results of compatibility studies with Plasma-Lyte 148 and commonly used

medications are awaited to inform any firmer recommendations related to the use of

Plasma-Lyte148 in paediatric and neonatal care.

Plasma-Lyte 148 is the only form of Plasma-Lyte considered appropriate in children. It is available with or without 5% glucose. Plasma-Lyte 148 and Plasma-Lyte 148 + 5% glucose contain 5mmol/L potassium chloride. The need for a product with a higher potassium chloride content is also under consideration.

7. DEVELOPMENT OF THE STANDARDS AND THE HEALTHSHARE NSW CONTRACT

The NSW Chief Paediatrician was tasked to lead a process of consensus, standardisation

and appropriate implementation of practice across all NSW facilities. The process

undertaken included extensive consultation and input from a range of experts across

medical, nursing, pharmacy and management domains from a variety of metropolitan and

rural settings. The composition of the NSW Standards for Paediatric IV Fluids Working

Party, subsequent Implementation Taskforce and Committee memberships for the second

edition are detailed in Appendix 1. Formal organisational consultations are listed in

Appendix 2.

Partnering with HealthShare NSW in understanding and informing procurement

requirements was identified as an essential, albeit complex, component. HealthShare

NSW undertook a formal tendering process leading to an appropriate contract,

incorporating the recommended paediatric IV fluids. The contracted products are detailed

in Table 1. HealthShare NSW continues to provide procurement advice to Local Health

Districts (LHDs).

Following the introduction of the first edition of the Standards, clinician expert feedback,

clinical incident reviews and product usage were closely monitored. An Information

Page 11: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 5 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

Bulletin (IB2014_066) was published to advise clinicians and managers about the

products and address procurement challenges associated with the implementation of the

Standards. It is important to recognise that costs, and consequently pricing, will be

influenced by, and modified according to, consumption across NSW and nationally.

Emerging new evidence and clinical experience motivated the early revision of the

Standards, with the resulting second edition15,16.

8. SYSTEM-WIDE ENGAGEMENT

The Standards described in this document address the appropriate choice of IV fluids and

measures related to their procurement, storage and safe administration. The Summary

Statement of Standards for Paediatric IV Fluids: NSW Health presents the key

messages and related actions on a single page (Page 6). These are not clinical practice

guidelines and do not address clinical assessment, calculations of fluid or electrolyte

requirements or their monitoring and appropriate responses to such data. It is noted,

however, that a number of existing clinical practice guidelines, educational resources and

other documents that specifically mention IV fluid content may need to be updated.

The NSW Paediatric IV Fluid Ordering chart is being revised to be consistent with the

Standards. The Paediatric IV Fluids education module in the Skills in Paediatrics (SkIP)

program is being revised. In addition, the DETECT Junior education resources (part of the

Between the Flags program) will be updated to reflect these Standards. The development

of any related resources by the Health Education and Training Institute (HETI) will also be

informed by these Standards. Educational resources related to the content and use of

Plasma-Lyte148 will be developed, as appropriate, to accompany future

recommendations for its use in paediatrics and neonates.

The related communication strategy includes correspondence to LHD Chief Executives,

SHNs, Pillars, clinician organisations as well as all partners engaged in the consultation

process.

9. RELATIONSHIP WITH NATIONAL INTERIM GUIDELINES

A number of changes have emerged from the CHA interim guidelines to the Standards for

Paediatric IV Fluids: NSW Health (first and second editions). These are summarised in

Appendix 4 In particular, while the CHA recommendations did not include neonatal

practice, the first edition of the Standards incorporated appropriate practice for neonates

presenting to emergency departments and/or readmitted to children’s wards. The practice

in special care and intensive care nurseries was not addressed in either document. The

second edition of the Standards incorporates special care nurseries but not intensive care

nurseries. Although CHA made certain recommendations for intra-operative and post-

operative fluid management, this is considered beyond the remit of the Standards at this

time. It is acknowledged that Hartmann’s Solution is used in peri-operative and intensive

care settings and balanced salt solutions are incorporated into the NSW Standards as

alternatives but only under the direction of medical specialists.

Page 12: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 6 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

10. SUMMARY STATEMENT OF STANDARDS FOR PAEDIATRIC INTRAVENOUS FLUIDS (Second Edition) The purpose of these standards is to enable safe and appropriate use of IV fluids for children and neonates across NSW.

IV FLUID CONTENT

FOR CHILDREN (excluding neonates)

Specialist consultation recommended if prescribing for infants < 3 months, when neonatal fluids may be more appropriate.

For Resuscitation / Bolus • 0.9% sodium chloride Alternatively and ONLY under direction of Specialist:

• other crystalloids, e.g. balanced salt solutions, or colloids may be used

For Replacement Fluids (dehydration or ongoing losses)

• 0.9% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L Alternatively and ONLY under direction of Specialist:

• Plasma-Lyte148 + 5% glucose

For Maintenance Fluids • 0.9% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L Alternatively and ONLY under direction of Specialist:

• 0.45% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L or • Plasma-Lyte148 + 5% glucose

If electrolytes are outside the normal range, discussion with a specialist is necessary

IV FLUID CONTENT

FOR NEONATES (less than one month of age corrected)

For neonates in neonatal nurseries (excluding neonatal intensive care), or presenting to emergency departments, or admitted to paediatric wards

For Resuscitation / Bolus • 0.9% sodium chloride

For Replacement (dehydration or ongoing losses) or Maintenance

Special Care Nurseries - DAY 1

• 10% glucose Special Care Nurseries – DAY 2 onwards

• 0.225% sodium chloride + 10% glucose +/- potassium chloride 10mmol/500mL

Emergency Departments

• 0.45% sodium chloride + 10% glucose (NO potassium chloride)

Paediatric Wards

• 0.45% sodium chloride + 10% glucose +/- potassium chloride 10mmol/500mL If electrolytes are outside the normal range, discussion with a specialist is necessary

IV FLUID BAGS PROCUREMENT AND USE

• It is strongly recommended that pre-packaged bags of appropriate IV fluids are available and

used with the correct concentrations of sodium, glucose and potassium, across all NSW facilities,

avoiding the practice of local additives, whenever possible.

• Fluids for children are recommended in 1000mL bags

• Fluids for neonates are recommended in 500mL bags

IV FLUID BAG LABELLING

• The content of the IV fluid bag will be clearly indicated in an easy to read font and a prominent

location on the IV fluid bag. Suitability for use in children will be indicated, where appropriate.

• IV fluids containing potassium chloride will clearly identify this additive.

• IV fluids containing 0.225%, 0.22% or 0.18% sodium chloride include a low sodium content warning.

• Bags used in children & neonates are expected to include ‘Infusion Pump Recommended’ on the label.

IV FLUID ADMINISTRATION

• NSW Health PD2010_034, states that “Paediatric infusion sets with inline burette must be used for all

children requiring intravenous therapy. An infusion pump should be used for all children”. For the

safety of paediatric and neonatal patients, both infusion pumps AND inline burettes are strongly

recommended with all maintenance and replacement fluids.

• All user-applied Labelling of Injectable Medicines, Fluids and Lines to follow the national Labelling

Recommendations.

• Hourly observations of the IV fluids and IV cannula site should be documented.

EDUCATION AND COMMUNICATION

• The Skills in Paediatrics (SkIP) education module is being updated.

• Relevant current education and information resources will be updated to reflect the second edition of

the Standards.

• The Standards are available via the NSW Kids and Families website.

ADDITIONAL SAFETY MEASURES

• If a child or neonate is prescribed IV Fluids not recommended in the Standards then please

clarify reason and document in medical notes.

• LHDs/ SHNs have been asked to ensure that, as a low sodium containing product for neonates,

0.225% sodium chloride should only be available with 10% glucose and be stored only in dedicated

maternity / neonatal storage unit.

• Fluids with 0.225%, 0.22% or 0.18% sodium chloride may continue to be used in adult practice but

should NOT be available for children.

• IV fluids containing potassium chloride are potentially hazardous and should be administered with

extreme caution.

Page 13: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 7 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

11. TABLE OF PAEDIATRIC INTRAVENOUS SOLUTIONS (Fluids incorporated in the Summary Statement of Standards for Paediatric IV Fluids: NSW Health)

CHILDREN NEONATES

Potassium chloride

20mmol

20mmol

Potassium chloride

10mmol

10mmol

5mmol

10%

10%

10%

10%

10%

Glucose 5%

5%

5%

5%

5%

Glucose

0.9%

0.9%

Sodium 140mmol

0.9%

Sodium chloride

0.45%

0.45%

Chloride 98mmol

0.45%

0.45%

Sodium chloride

0.22%

0.225%

Magnesium

1.5mmol

Magnesium

Acetate

27mmol

Acetate

Gluconate

23mmol

Gluconate

1000mL

1000mL

1000mL

1000mL

1000mL

1000mL

Bag size 500mL 500mL 500mL 500mL 500mL 500mL

Bag size

0.9%

Sodium chloride +

5% Glucose (1000mL)

0.9% Sodium

chloride + 5% Glucose + 20mmol Potassium chloride

(1000mL)

0.45% Sodium

chloride + 5% Glucose (1000mL)

0.45% Sodium

chloride + 5%+

Glucose 20mmol

Potassium chloride

(1000mL)

Plasma-Lyte 148 + 5% Glucose

(1000mL)

0.9% Sodium Chloride

(500mL or 1000mL)

10% Glucose (500mL)

0.22% Sodium

chloride + 10%

Glucose (500mL)

0.225% Sodium

chloride + 10%

Glucose + 10mmol

Potassium chloride (500mL)

0.45% Sodium

Chloride + 10%

Glucose (500mL)

0.45% Sodium

chloride + 10%

Glucose + 10mmol

Potassium chloride (500mL)

Please refer to the latest iteration of the 904 contract Guide and the Product & Pricing Schedule for up-to-date product & pricing information. For further information please contact your contract manager at: [email protected]. Demand is to be monitored for future value proposals. NSW Health Administration Corporation Contract 904 Intravenous and Parenteral Nutritional Fluids plus Irrigating Solutions Suppliers: contact Baxter Healthcare Australia for sole supply fluids and Baxter Pharmacy Services for compounded fluids (please note that there are multiple suppliers on the 904 contract for glucose 10% 500mL & sodium chloride 0.9% 500mL & 1000mL fluids)

Page 14: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 8 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

12. APPENDICES 12.1. Appendix 1 – Standards for Paediatric IV Fluids: NSW Health

Working Group and Implementation Taskforce Membership Committee membership (Second Edition)

Name Position

Prof Les White

Chair

NSW Chief Paediatrician, NSW Kids and Families

Sandra Babekuhl Paediatric Clinical Nurse Consultant, Mid North Coast LHD

Peter Barclay Director of Pharmacy, Sydney Children’s Hospitals Network, Westmead

Pauline Best Paediatric Nurse Educator, St George Hospital, SESLHD

Dr Srinivas Bolisetty Senior Staff Specialist, Newborn Services, Royal Hospital for Women

Dr Paul Craven Neonatologist, Hunter New England LHD

Dr Stuart Crisp Rural Paediatrician, Western NSW LHD

Mandy Crowley Baxter Healthcare

Deborah Endean Pharmaceutical Contracts Manager, HealthShare NSW

Dr Joanne Ging

Head of General Medicine, Sydney Children's Hospitals Network,

Westmead

Dr Robert Guaran Neonatologist, NSW Pregnancy and newborn Services Network

Catherine Jones Standardisation of Care Coordinator, Paediatric Healthcare Team, NSW Kids and Families

Margaret Kelly Senior Manager, Paediatric Healthcare Team, NSW Kids and Families

Tina Kendrick Clinical Nurse Consultant, Newborn & paediatric Emergency Transport Service

Gail Mondy Director, Maternal, Child & Family Health, NSW Kids and Families

Dr Rob Morton Rural GP, VMO, Southern NSW LHD

Dr Kristen Neville

Endocrinologist, Sydney Children’s Hospitals Network, Randwick

Dr Susan Phin Staff Specialist, Emergency Department, Sydney Children's

Hospitals Network, Westmead

Tomas Ratoni Paediatric Clinical Nurse Consultant, Northern NSW LHD

Dr David Schell Intensivist, PICU, Sydney Children’s Hospitals Network, Westmead

Natalie Tasker Medication Safety Pharmacist, Sydney Children’s Hospitals Network

Jane Wardle Neonatal Clinical Nurse Consultant, Gosford Hospital, Central Coast LHD

Ian Wright Professor of Paediatrics, Wollongong Hospital, Illawara Shoalhaven LHD

Page 15: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 9 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

Neonatal IV Fluids sub-committee membership (Second Edition)

Name Position

Dr Paul Craven

Chair

Neonatologist, Hunter New England LHD

Pauline Best Paediatric Nurse Educator, St George Hospital, South Eastern Sydney LHD

Dr Srinivas Bolisetty Senior Staff Specialist, Newborn Services, Royal Hospital for Women

Dr Stuart Crisp Rural Paediatrician, Western NSW LHD

Dr Joanne Ging

Head of General Medicine, Sydney Children’s Hospitals Network, Westmead

Dr Robert Guaran Neonatologist, NSW Pregnancy and newborn Services Network

Dr Keith Howard Paediatrician, Hunter New England LHD/ Medical Lead Children’s Healthcare Network, Northern

Catherine Jones Standardisation of Care Coordinator, Paediatric Healthcare Team, NSW Kids and Families

Tina Kendrick Clinical Nurse Consultant, Newborn & paediatric Emergency Transport Service

Dr Rob Morton Rural GP, VMO, Southern NSW LHD

Dr Matthew O’Meara Head of Emergency, Sydney Children’s Hospitals Network, Randwick

Dr Susan Phin Staff Specialist, Emergency Department, Sydney Children's Hospitals Network, Westmead

Tomas Ratoni Paediatric Clinical Nurse Consultant, Northern NSW LHD

Dr Robert Slade Paediatrician, Northern Sydney LHD/ Medical Lead Children’s Healthcare Network, Southern

Helen Stevens Paediatric Clinical Nurse Consultant, Hunter New England LHD

Jane Wardle Neonatal Clinical Nurse Consultant, Gosford Hospital, Central Coast LHD

Ian Wright Professor of Paediatrics, Wollongong Hospital, Illawarra Shoalhaven LHD

Page 16: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 10 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

Working Group membership (First Edition)

Name Position

Dr Kristen Neville

Co-Chair

Endocrinologist, Sydney Children’s Hospitals Network, Randwick

Dr Joanne Ging

Co-Chair

Clinical Director, Division of Women’s Children’s and Family

Health, Hornsby Ku-ring-gai Health Service, Northern Sydney

LHD Prof Les White

Sponsor

NSW Chief Paediatrician, NSW Kids and Families

Dr Chris Webber Deputy Medical Director, Newborn & paediatric Emergency Transport Service and Emergency Physician, Sydney Children’s Hospitals Network

Dr Damien McKay Chief Resident Medical Officer, Sydney Children’s Hospitals Network, Westmead

Elizabeth Kepreotes Clinical Improvement Coordinator, John Hunter

Children’s Hospital, Kaleidoscope

Karyn Fahy Co-ordinator, Western Child Health Network

Pauline Best Paediatric Nurse Educator, St George Hospital, South Eastern Sydney LHD

Peter Barclay Deputy Director of Pharmacy, Sydney Children’s Hospitals Network, Westmead

Dr Richard Lennon Emergency Specialist, Royal North Shore Hospital, Northern Sydney LHD

Dr Rob Morton Rural GP, VMO, Southern NSW LHD

Robert Pearce Director of Pharmacy, John Hunter Children’s Hospital, Hunter New England LHD

Sandra Babekuhl Paediatric Clinical Nurse Consultant, Mid North Coast LHD

Dr Sean Kennedy Nephrologist, Sydney Children’s Hospitals Network, Randwick

Dr Stuart Crisp Rural Paediatrician, Western NSW LHD

Dr Susan Phin Staff Specialist, Emergency Department, Sydney Children’s

Hospitals Network, Westmead

Trish Boss Program Manager, Paediatric Services, Statewide and Rural

Health Services and Capital Development Branch, NSW

Ministry of Health (MoH)

Dr Bruce King Endocrinologist, John Hunter Children’s Hospital, Hunter New England LHD

Page 17: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 11 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

Implementation taskforce membership (First Edition)

Name Position

Prof Les White

Chair

NSW Chief Paediatrician, NSW Kids and Families

Roger Oswald Team Leader, Business Procurement Services, HealthShare NSW

Deborah Endean Pharmaceutical Contracts Manager, HealthShare NSW

Dr Kristen Neville Endocrinologist, Sydney Children’s Hospitals Network, Randwick

Dr Joanne Ging Clinical Director, Division of Women’s Children’s and Family

Health, Hornsby Ku-ring-gai Health Service, Northern Sydney

LHD

Trish Boss Program Manager, Paediatric Services, Statewide and Rural

Health Services and Capital Development Branch, NSW

Ministry of Health

Peter Barclay Deputy Director of Pharmacy, Sydney Children’s Hospitals Network, Westmead

Sandra Babekuhl Paediatric Clinical Nurse Consultant, Mid North Coast LHD

Dr Rob Morton Rural GP, VMO, Southern NSW LHD

Dr Stuart Crisp Rural Paediatrician, Western NSW LHD

Pauline Best Paediatric Nurse Educator, St George Hospital, South Eastern Sydney LHD

Margaret Kelly Greater Eastern and Southern Child Health Network

Page 18: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 12 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

12.2. APPENDIX 2 - Consultation Undertaken Formally With Relevant Organisations in Developing the Standards for Paediatric IV Fluids: NSW Health (First Edition)

Position Organisation

Chief Executive Ambulance Service of NSW

Chair Anaesthetic Advisory Group

Medical Science Liaison,

Medication Delivery; Market

Manager, Medication Delivery;

Business Manager

Baxter Healthcare Australia Pty Ltd

Chief Executive Children’s Healthcare Australasia

Chief Executive Clinical Excellence Commission

Pharmaceutical Contracts Manager;

Team Leader Business Procurement Services

HealthShare NSW

Chair Metropolitan Level 4 Paediatric Units

State Director Newborn and paediatric Emergency Transport

Service

Coordinators and CNCs NSW Children’s Healthcare Network

Chief Pharmacist NSW Health

Chair NSW Health Forms Committee

Operations Manager NSW Pregnancy and newborn Services Network

Chair NSW Rural Doctors Network

Chair Paediatric Intensive Care Advisory Group

Chair Pharmacy Advisors Group, NSW Ministry of Health

President Rural Doctors Association

Director Critical Care Sydney Children’s Hospitals Network, Randwick

Director of Anaesthesia Sydney Children’s Hospitals Network, Westmead

Page 19: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 13 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

12.3. APPENDIX 3 – Labelling practice For base fluids (proposed label with paediatric advisory statement*)

* Product label for AHB1064 as it currently appears in the Paediatric Standards is not an approved TGA product label

Batch, expiry and recyclable symbol denoted here

Advisory statements added for paediatrics

Reverse printing in product label to differentiate from

other solutions

Page 20: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 14 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

For high risk additives

Batch, expiry and recyclable symbol denoted here

Advisory statements added for paediatrics

Barcode added

Standardisation of units used, keeping in mind TGA

requirements for future registration

Emphasis on high-risk active ingredient

Red ink to be used to highlight potassium

content

Critical information moved to the bottom which remains

visible as the bag empties

Page 21: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 15 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

For low sodium solutions

Batch, expiry and recyclable symbol denoted here

Australian made symbol added

Cautionary statement differs for low sodium

containing solutions

Page 22: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015

Page 16 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

For balanced salt solutions

Batch, expiry and recyclable symbol denoted here

The new format minimises label

clutter, placing emphasis on

important clinical

information such as solution

ingredients,

concentration and tonicity.

.

Page 23: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 17 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

12.4. APPENDIX 4 – Summary table of stages in development of the Standards for Paediatric IV Fluids

Indication CHA Recommendation NSW Standards for Paediatric IV Fluids (1st

Edition) NSW Standards for Paediatric IV Fluids (2nd Edition)

Resuscitation/ Bolus

0.9% sodium chloride or Hartmann’s (NO glucose)

0.9% sodium chloride

OR

Hartmann’s Solution or Plasma-Lyte 148 (NO glucose)

0.9% sodium chloride

Alternatively and ONLY under direction of Specialist:

other crystalloids, e.g. balanced salt solutions, or colloids may be used

Replacement

(dehydration or

ongoing losses)

0.9% sodium chloride +5% glucose +/-20mmol/L potassium

chloride

0.9% sodium chloride +5% glucose +/-20mmol/L potassium chloride OR

Plasma-Lyte148 + 5% glucose (Children’s Hospitals only)

0.9% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L

Alternatively and ONLY under direction of Specialist:

Plasma-Lyte148 + 5% glucose

If electrolytes are outside the normal range, discussion with a specialist is necessary

Maintenance 0.45% sodium chloride +5% glucose +/-20mmol/L potassium chloride

0.45% sodium chloride + 5% glucose +/- 20mmol/L potassium chloride

(note discretionary use of potassium chloride consistent with CHA recommendation)

OR especially where there is pre-existing hyponatraemia, or non-osmotic ADH

secretion (e.g. post-op, respiratory, CNS disease) 0.9% sodium chloride + 5% glucose +/- 20mmol/L potassium chloride OR Plasma-Lyte148 + 5% glucose (Children’s Hospitals only)

0.9% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L

Alternatively and ONLY under direction of Specialist:

0.45% sodium chloride + 5% glucose +/- potassium chloride 20mmol/L,

or Plasma-Lyte148 + 5% glucose

If electrolytes are outside the normal range, discussion with a specialist is necessary

Peri and intra-operative period

0.9% sodium chloride +1% glucose

1% glucose solutions NOT supported

Further consultation with paediatric anaesthetic professional and state organisations recommended. Hartmann’s solution often used peri-operatively.

No change from 1st Edition

Neonates (<1 month corrected) (The 2nd Edition Standards for Paediatric IV Fluids: NSW Health incorporates Special Care Nursery practices (not NICU)

Resuscitation/ Bolus

0.9% sodium chloride or Hartmann’s (NO glucose)

0.9% sodium chloride

0.9% sodium chloride

Replacement

(dehydration or ongoing losses)

No recommendation 0.45% sodium chloride +10% glucose +/- 20mmol/L potassium chloride OR

0.9% sodium chloride +10% glucose +/- 20mmol/L potassium chloride may be used with expert supervision.

Special Care Nurseries - DAY 1

10% glucose

Special Care Nurseries – DAY 2 onwards

0.225% sodium chloride + 10% glucose +/- potassium chloride 10mmol/500mL

Emergency Departments

0.45% sodium chloride + 10% glucose (NO potassium chloride)

Paediatric Wards

0.45% sodium chloride + 10% glucose +/- potassium chloride 10mmol/500mL

If electrolytes are outside the normal range, discussion with a specialist is necessary

Maintenance No recommendation (Day1-3) 10% glucose

(>3 days) 0.225% sodium chloride +10% glucose +/- 20mmol/L potassium chloride OR

0.45% sodium chloride +10% glucose +/- 20mmol/L potassium chloride, where there is

pre-existing or risk of hyponatraemia or non-osmotic ADH secretion (e.g. post-op, respiratory, CNS diseases).

Page 24: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 18 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

12.5. APPENDIX 5 – References 1. Moritz ML, Ayus JC. Prevention of Hospital-Acquired Hyponatremia: A Case for Using

Isotonic Saline. Pediatrics, 2003;111(2):227-30.

2. Neville KA, Verge CF, Rosenberg AR, O’Meara MW, Walker JL. Isotonic is better than

hypotonic saline for intravenous rehydration of children with gastroenteritis: a

prospective randomised study. Archives of Disease in Childhood, 2006;91(3):226-32.

3. Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised

children: a systematic review. Archives of Disease in Childhood, 2006;91(10):828-35.

4. Montañana PÁ, Modesto i Alapont V, Ocón AP, López PO, López Prats JL, Toledo

Parreño JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic

hyponatremia in pediatrics: A randomized, controlled open study. Pediatric Critical

Care Medicine, 2008;9(6):589-97.

5. Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids.

Journal of Paediatrics and Child Health, 2009;45(1-2):9-14.

6. Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL.

Prevention of Hyponatremia during Maintenance Intravenous Fluid Administration: A

Prospective Randomized Study of Fluid Type versus Fluid Rate. The Journal of

Pediatrics, 2010;156(2):313-9.

7. Drysdale S, Coulson T, Cronin N, Manjaly Z-R, Piyasena C, North A, et al. The impact

of the National Patient Safety Agency intravenous fluid alert on iatrogenic

hyponatraemia in children. Eur J Pediatr, 2010;169(7):813-7.

8. Moritz M, Ayus J. Improving intravenous fluid therapy in children with gastroenteritis.

Pediatr Nephrol, 2010;25(8):1383-4.

9. Moritz ML, Ayus JC. Prevention of Hospital-Acquired Hyponatremia: Do We Have the

Answers? Pediatrics, 2011;128(5):980-3.

10. National Patient Safety Agency UK. Reducing the risk of hyponatraemia when

administering intravenous infusions to children. Patient Safety Alert, 2007.

11. Institute for Safe Medication Practices Canada. Hospital-Acquired Acute

Hyponatremia: Two Reports of Pediatric Deaths. ISMP Canada Safety Bulletin,

2009;9(7).

12. Institute for Safe Medication Practices (US). Plain D5W or hypotonic saline solutions

post-op could result in acute hyponatremia and death in healthy children. Medication

Safety Alert Acute Care, 2009.

13. Myburgh JA, Mythen MG. Critical Care Medicine Review: Resuscitation Fluids. N Engl

J Med, 2013: 369: 1243-51.

Page 25: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 19 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

14. Plasma-Lyte 148 Replacement IV Infusion. Baxter Product Information 05JUL2013

http://www.baxterhealthcare.com.au/downloads/healthcare_professionals/cmi_pi/

plasmalyte148_pi.pdf

15. McNab S, Duke T, South M, Babl FE, Lee KJ, Arnup SJ, Young S, Turner H, Davidson

A. 140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous

fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial.

Lancet. 2015 Mar 28;385(9974):1190-7

16. McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A,

Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid

administration in children (Review). Cochrane Library 2014, Issue 12

17. Australian Commission on Safety and Quality in Health Care, National

Recommendations for User-applied Labelling of Injectable Medicines, Fluids and

Lines, 2012

18. Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB,

Comparison of Isotonic and Hypotonic Intravenous Maintenance Fluids: A

Randomized Clinical Trial, JAMA Pediatr. Published online March 09, 2015.

19. User applied Labelling of Injectable Medicines, Fluids and Lines, NSW Health

(PD2012_007)

Page 26: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 20 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)

NOTES

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Page 27: 2015 NSW Health Paediatric Standards V2

GL2015_008 Issue date: August 2015 Page 21 of 20

Standards for Paediatric IV Fluids: NSW Health (second edition)