PAEDIATRIC DOSAGE GUIDELINES For management of post-operative acute pain

Index No: MMG43 PAEDIATRIC DOSAGE GUIDELINES For management of post-operative acute pain Version: 3.1 (Includes anti-emetics and naloxone) Date ratified: July 2013 Ratified by: (Name of Committee) Name of originator/author, job title and department: Director Lead (Trust-wide policies) Associate Medical Director (local Policies) Clinical Management Team / Directorate Applicable to Name of responsible committee for the policy: Surgery CMTG Nirav Sheth Pharmacist Pharmacy Medical Director Surgery Date issued for publication: July 2013 Review date: April 2016 Expiry date: (Date 3 months following review date) Equality impact assessed by: (name, job title and department) Chris Moore Pharmacist Pharmacy Medicines Management Committee July 2016 Registration Requirements Outcome Outcome 9 Number(s) (CQC) NHSLA standard 5.10 This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a CNST standard N/A Page 1 of 14

CONTRIBUTION LIST Individuals involved in developing the document Name Nirav Sheth Chris Moore Rachel Revie Beverley Bone Designation Pharmacist Surgery Lead Pharmacist Lead Acute Pain Nurse Theatre recovery manager Circulated to the following individuals for consultation Name Linda Twohey Designation Consultant Anaesthetist Page 2 of 14

Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this process. Name Job Title Signature Date Local Committee approval (where applicable) Name of Committee Name of Chairperson Surgery CMTG Mr Al-Hamali Date of Approval Change History Version Date Author Reason 3 Feb 2010 Beverly Bone Update to doses 3.1 Oct 2013 Document restored from archive and converted from Trust Policy format to Medicines Management Guideline format Impact Assessment This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a A translation service is available for this policy. The Interpretation/Translation Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide policies. Contents Page 3 of 14

Section Page 1.0 Introduction 5 2.0 Mild to moderate pain 6 3.0 Severe pain 8 4.0 Post-operative nausea and vomiting (PONV) 10 5.0 Monitoring arrangements for compliance and effectiveness 11 6.0 Plan for dissemination and implementation 11 7.0 References 11 Appendix 1 Paracetamol doses at discharge 12 Appendix 2 NCA/PCA Morphine doses 13 Appendix 3 Codeine MHRA warning update 14 Page 4 of 14

1.0 Introduction These guidelines are focused on dosage ranges. For more comprehensive information the book BNF for Children should be consulted. Where information on doses has been taken from sources other than BNF for children (2012/13), this will be clearly identified in the text in blue italics. A patient group direction (PGD) on oral paracetamol prescribing for elective surgical patients on paediatric wards is available on the medicines management page of the hospital intranet. All post-operative analgesia prescriptions should not be given for longer than 48 hours without review. NOTE: The giving of INTRAMUSCULAR INJECTIONS is not normal practice on children unless there is no alternative route of administration. Analgesia given on the paediatric wards at KGH is only administered in the form of oral or rectal medication. All oral medication is administered using oral syringes, dedicated only for this purpose. Only syringes with purple plungers should be used for the administration of oral/enteral liquid medicines: There have been a number of deaths and serious incidents following administration of oral/enteral liquid medicines via the intravenous route (e.g. oramorph being drawn up in IV syringe and administered intravenously). All oral/enteral syringes should be labelled ( oral and/or enteral ) to aid selection and use. If not used immediately after preparation, the syringe must be labelled appropriately (name and strength of medicine, patient s name, date and time it was prepared by the person who has prepared the syringe). Post-operative INTRAVENOUS bolus opiate analgesia is only administered in the recovery room, where nurses have achieved the required competency under the Scope of Practice, and the immediate assistance of an anaesthetist is available. The appendices include dose-banding information regarding paracetamol and morphine PCA. The dose volumes cited indicate how pharmacy may round up/down prescribed doses of discharge medications, according to the body weight, to make it easier for parents and carers to administer at home. Page 5 of 14

2.0 MILD TO MODERATE PAIN PARACETAMOL Oral and Rectal loading dose: 30mg/kg. Refer to the following for subsequent (maintenance) dosing Oral (PO) AND rectal (PR) maintenance dosing Age 1 month 6 years 15mg 20mg /kg/dose - 6-8 hourly Max. daily dose: 90mg/kg in divided doses Age 6 12 years 15mg 20mg /kg/dose 4-6 hourly Max. daily dose: 90mg/kg in divided doses (Max 4g) Age 12 18 years 1g every 4-6 hours Max 4 doses in 24 hours Intravenous (IV) dosing Weight < 10kg 7.5mg/kg/dose 4 6 hourly Max. daily dose: 30mg/kg in divided doses Weight 10 50kg 15mg/kg/dose 4 6 hourly Max. daily dose: 60mg/kg in divided doses Weight > 50kg 1g 4 6 hourly Max. daily dose: 4g in divided doses The above doses should be given for a maximum of 48 hours before review Rectal dosing choose the nearest suppository strength and adjust frequency so total daily dose is not exceeded. Intravenous administration give as an infusion over 15 minutes. A 50ml (500mg) vial can be further diluted with 0.9% Sodium Chloride or 5% Glucose to a maximum volume of 500ml If different preparations are required, prescribe as separate entries on the PRN medication section of the drug chart with the corresponding dose for each route. CAUTIONS Renal impairment: Increase infusion dose interval to every 6 hours if egfr < 30ml/min Hepatic impairment: High risk of liver toxicity with high doses in patient with chronic malnutrition, dehydration. Reduce max. daily infusion dose to 3g in divided doses Page 6 of 14

IBUPROFEN Oral (PO) maintenance dosing Age 1 3 months 5mg/kg/dose 6-8 hourly Age > 3 months 5 10mg/kg/dose 6-8 hourly Max. daily dose: 30mg/kg in divided doses (up to max. 2.4g daily) Doses from Leicester Royal Infirmary Children s Hospital Paediatric analgesia guidelines and BNFC (12/13) CAUTIONS Renal impairment: Use with caution with monitoring or renal function. Hepatic or cardiac impairment: Use with caution. Children with asthma: Use with caution with monitoring of respiratory function. DICLOFENAC Oral (PO) and rectal (PR) maintenance dosing Age < 6 months Age 6 months NOT RECOMMENDED 0.3 1mg/kg/dose (max 50mg total dose) 8 hourly Max. daily dose: 3mg/kg/24 hours or 150mg in divided doses Rectal dosing choose the nearest suppository strength to the weight and adjust frequency so total daily dose is not exceeded. CAUTIONS (See above, as for ibuprofen) CODEINE PHOSPHATE Oral (PO) maintenance dosing (Tablets are not licensed for use in children < 12 years; Intravenous (IV) route should be avoided - causes histamine release, resulting in reduced cardiac output) Dose 0.5 1mg/kg/dose 4-6 hourly Max. daily dose: 240mg in divided doses CAUTIONS PLEASE CONSULT APPENDIX 3 FOR THE LATEST MHRA CONTRAINDICATIONS RELATING TO AGE AND INDICATIONS Page 7 of 14

3.0 SEVERE PAIN MORPHINE SULPHATE Oral (PO) maintenance dosing (using 10mg/5ml oral solution not licensed for use in children < 1 year) Age 1 12 months 80 200 micrograms/kg/dose up to 4 hourly Age 1 2 years 200 400 micrograms/kg/dose up to 4 hourly Age 2 12 years 200 500 micrograms/kg/dose up to 4 hourly (Maximum 20mg/dose) Age 12-18 years 5mg 20mg dose Doses from Leicester Royal Infirmary Children s Hospital Paediatric analgesia guidelines Intravenous (IV) Bolus dosing Max. daily dose: 2.5mg/kg/24hours (Max. 6 doses in 24 hours) Use lowest dose first. Age < 1 month Age 1 6 months Age 6 months 12 years Age 12 18 years 50 micrograms/kg/dose 6 hourly 100 micrograms/kg/dose 6 hourly 100 micrograms/kg/dose 4-6 hourly 5mg 10mg 4-6 hourly Administration: Intravenous bolus given over at least 5 minutes. Use lowest dose first. Doses from BNFC 12/13 Intravenous (IV) administration via PCA pump Weight < 50kg Total amount of morphine = 1mg/kg (up to max. 50mg), in 50ml normal saline to give final concentration of 20mcg/kg/ml Loading dose volume (prior to starting PCA) = 2.5 5ml STAT Bolus dose volume = 1ml, followed by 5-minute lockout period Weight 50kg Use 50mg/50ml pre-filled syringe See above for dose volumes, as for patient weight < 50kg Doses from Leicester Royal Infirmary Children s Hospital Paediatric analgesia guidelines Examples: Child weighing 33kg = 33mg morphine sulphate made up to 50ml Sodium Chloride 0.9% Child weighing 44kg = 44mg morphine sulphate made up to 50ml Sodium Chloride 0.9% Child weighing 55kg = Use 50mg/50ml pre-filled syringe Page 8 of 14

CAUTIONS (See codeine phosphate) High risk of respiratory depression in children < 12 months. Monitor respiratory rate after each dose, consider monitoring of oxygen saturation. RESPIRATORY MONITORING IS ESSENTIAL!!! PETHIDINE Pethidine may be used if there are known sensitivities to morphine administration. Oral (PO) dosing (for smaller doses, the injection may be given orally) Age: 2 months - 12 years Age 12 years 500micrograms 2mg/kg/dose 4-6 hourly PRN 50 100mg 4-6 hourly PRN Maximum 1mg/kg/dose 12 hourly for neonates increased susceptibility to respiratory depression Doses from Medicines for Children (2003) Intravenous (IV) dosing Age < 12 years 500 micrograms 1mg/kg/dose 4-6 hourly PRN (12 hourly if less than 2 months old) Age 12 years 25 50mg 4-6 hourly PRN Doses from Medicines for Children (2003) Minimum 12 hourly dosing for neonates increased susceptibility to respiratory depression CAUTIONS Avoid in severe renal and hepatic impairment High risk of respiratory depression in children < 12 months. Monitor respiratory rate after each dose, consider monitoring of oxygen saturation. Page 9 of 14

NALOXONE To be used in cases of over-dosage with opioids or post-operative respiratory depression Intravenous (IV) bolus dosing Age < 12 years 1 microgram /kg/dose Repeat every 2 3 minutes if required Age 12 years 1.5 microgram 3 microgram/kg/dose If response inadequate give subsequent doses of 100 micrograms every 2 3 minutes if required 4.0 POST-OPERATIVE NAUSEA & VOMITING (PONV) Anti-emetics given intra-operatively will help in the prevention of PONV, particularly when opioid analgesia has been used. Ondansetron is the drug of choice, because cyclizine injection is not licensed for use in children. However, the use of cyclizine is effective and common in young children. ONDANSETRON Intravenous (IV) bolus dosing Age: > 1 month 18 years 100 micrograms /kg /dose 8 hourly (Max. 4mg/dose) Administration: Intravenous bolus given over 2 5 minutes. CYCLIZINE By Mouth OR Intravenous (IV) bolus dosing Age 1 month 6 years Age 6 12 years Age 12 18 years 0.5 1mg/kg/dose 8 hourly (Max. 25mg/dose) 25mg 8 hourly 50mg 8 hourly Administration: Intravenous bolus given over at 3 5 minutes. Page 10 of 14

5.0 MONITORING ARRANGEMENTS FOR COMPLIANCE AND EFFECTIVENESS Aspect of compliance or effectiveness being monitored The document is intended to guide prescribers. Adherence is not mandatory and so compliance monitoring is not required. Monitoring method See above Responsibility for monitoring See above Frequency of monitoring See above Responsible committee for monitoring and implementation of required actions See above 6.0 PLAN FOR DISSEMINATION AND IMPLEMENTATION This guideline will be implemented and disseminated via the following methods: Placed on the hospital intranet sites E-mail briefing to relevant clinicians and pharmacy staff 7.0 References: 1. Medicines Management Clinical Committee (2007) 2. BNF for children: BMJ publishing Group Ltd (2012/13) 3. Guy s and St Thomas, King s College and University Lewisham Hospitals Paediatric Formulary 7 th Edition (2005) 4. NGH NHS Trust: Children s Unit, Guidelines for Children s Pain Management. Compiled by J Margetts (2002) 5. Medicines for Children. Royal College of Paediatrics and Child Health (2003) 6. Leicester Royal Infirmary Children s Hospital Paediatric Analgesia Guidelines (2009) Page 11 of 14

Appendix 1 Paracetamol doses at discharge Oral dose: 15mg/kg every 4-6 hours. Maximum 90mg/kg or 4g/day Weight Dose Frequency Max m dose (kg) (mg) Oral Rectal 4.2 60 60 q 6-8hours 60mg/kg/ 4.5 60 60 q 6-8hours day in divided doses 5.6 60 60 q 6-8hours 6.5 90 125 qds 4 doses 6.9 90 125 qds 4 doses 7.7 90 125 qds 4 doses 8 120 125 qds 4 doses 8.5 120 125 qds 4 doses 8.6 120 125 qds 4 doses 9.2 125 125 qds 4 doses 9.6 125 125 qds 4 doses 10 125 125 qds 4 doses 13.5 250 250 qds 4 doses 15 250 250 qds 4 doses 17.5 250 250 qds 4 doses 18 250 250 qds 4 doses 21.8 250 250 qds 4 doses 23 375 250 qds 4 doses 27.7 375 500 qds 4 doses 29 375 500 qds 4 doses 30 500 500 qds 4 doses 39 500 500 qds 4 doses 39 500 500 qds 4 doses 50 500 1g 500-1g qds 4 doses Page 12 of 14

Appendix 2 NCA/PCA Morphine Doses Weight (kg) Dose (mg / 50ml) Dose (microgram/ml) 15 15 300 16 16 320 17 17 340 18 18 360 19 19 380 20 20 400 21 21 420 22 22 440 23 23 460 24 24 480 25 25 500 26 26 520 27 27 540 28 28 560 29 29 580 30 30 600 31 31 620 32 32 640 33 33 660 34 34 680 35 35 700 36 36 720 37 37 740 38 38 760 39 39 780 40 40 800 41 41 820 42 42 840 43 43 860 44 44 880 45 45 900 46 46 920 47 47 940 48 48 960 49 49 980 50 50 1000 (1mg) Page 13 of 14

Appendix 3 Codeine MHRA warning update Advice for healthcare professionals: Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone Codeine is now contraindicated in: all children age 0 18 years who undergo tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea all patients of any age known to be CYP2D6 ultra-rapid metabolisers Codeine is not recommended for use in children whose breathing might be compromised, including those with: neuromuscular disorders; severe cardiac or respiratory conditions; upper respiratory or lung infections; multiple trauma; or extensive surgical procedures. Morphine toxicity may be increased in these settings In children age 12 18 years, the maximum daily dose should not exceed 240 mg. This may be taken in divided doses up to four times a day at intervals of no less than 6 hours. It should be used at the lowest effective dose for the shortest period. Duration of treatment should be limited to 3 days and if no effective pain relief is achieved, treatment should be reviewed by a physician Information should be given to parents and caregivers on how to recognise the signs and symptoms of morphine toxicity, and advice should be given to stop giving the child codeine and to seek medical attention immediately if the child shows these signs or symptoms, which include: reduced levels of consciousness; somnolence; respiratory depression; pin-point pupils; lack of appetite; constipation; or nausea and vomiting Page 14 of 14