WHO Persisting Pediatric Pain Guidelines: A Research Agenda
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1 WHO Persisting Pediatric Pain Guidelines: A Research Agenda Third Partners Meeting on Better Medicines for Children 22 November 2011, Geneva Willem Scholten, PharmD, MPA Team Leader, Access to Controlled Medicines World Health Organization
2 Adequacy Consumption of Opioid Analgesics (2007) Based on: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18 2
3 Uses of Controlled Medicines Opioid analgesics: e.g. morphine moderate to severe pain Long-acting opioid agonists: methadone, buprenorphine treatment of opioid dependence Ergometrine and ephedrine: emergency obstetrics Benzodiazepines: anxiolytics, hypnotics, antiepileptics Phenobarbital: antiepileptic 3
4 WHO Cancer Pain and Palliative Care in Children (1998) Systematic approach: "By the ladder" "By the clock" "By the appropriate route" "By the individual" Three Step Analgesic Ladder Obsolete now for some recommended opioids E.g. levorphanol, pethidine Not evidence-based / no transparency 4
5 WHO Guidelines on Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses In Print - Expected Q Evidences-based and transparent Focus on pharmacological treatment When opioids when non-opioids 20 treatment guidelines + 4 health systems guidelines 5
6 Selected Recommendations Principle: All moderate and severe pain in children should always be addressed. Two Step Approach according to the child's level of pain severity. First step: paracetamol or ibuprofen (mild pain) both to be made available Second step: morphine (moderate to severe pain) Please note: codeine is no longer recommended; tramadol also not recommended 6
7 However For most recommendations: evidence levels assessed "low" and "very low" Several clinical questions could not be answered Research agenda Published in: Evidence Based Child Health 6: (2011) 7
8 Citation Barbara Milani, Nicola Magrini, Andy Gray, Phil Wiffen and Willem Scholten WHO Calls for Targeted Research on the Pharmacological Treatment of Persisting Pain in children with Medical Illnesses Evid.-Based Child Health 6: (2011) DOI: /(ebch.777) 8
9 SRs and RCTs (1) 2-step vs 3-step; comparison effectiveness of analgesics 2 RCTs 1 SR of RCTs Benefits vs harms of opioids none Comparison effectiveness & harms of strong opioids/routes of administration 9 RTCs Opioids rotation and switching none 9
10 SRs and RCTs (2) SR vs IR morphine formulations none Episodic or breakthrough pain none Adjuvant medicines to relieve pain none 10
11 WHO Call for Research Identified Research Gaps Clinical studies needed on paracetamol, NSAIDs and opioid analgesics 8 research topics Clinical studies needed on adjuvant medicines for neuropathic pain Pharmacokinetics Pain assessment tools 11
12 Studies on paracetamol, NSAIDs and opioid analgesics (1) (Pls see publication for details) Long term safety data paracetamol and NSAIDS Comparisons of strong opioids (effectiveness, safety, feasibility of use in persisting pain) Efficacy and safety of intermediate potency opioid analgesics (<12 yrs) e.g. tramadol Assessment of two step treatment strategy 12
13 Studies on paracetamol, NSAIDs and opioid analgesics (2) (Pls see publication for details) Opioid dose conversion, age group specific RCTs of short acting opioids for breakthrough pain Opioids rotation policies, including prevention of adverse effects, tolerance and dose escalation) 13
14 Studies on adjuvant medicines (Pls see publication for details) Studies on efficacy in neuropathic pain Antidepressants(TCAs, SSRIs, SNRIs) Gabapentin Ketamine (in refractory pain) 14
15 Other studies needed Pharmacokinetics of opioids and non-opioid analgesics Neonates, infants, children Naloxone dosing in opioid tolerant children Pain assessment tools Validation of observational behaviour tools in Neonates, infants and preverbal children and children with developmental problems Multidimensional tools Different socio-cultural contexts 15
16 Research coordination International Childrens Palliative Care Network Executive Director Dr Joan Marston Combining sites for statistical power Registry of ongoing research 16
17 WHO Persisting Pediatric Pain Guidelines: A Research Agenda Willem Scholten, PharmD, MPA Team Leader, Access to Controlled Medicines Essential Medicines and Pharmaceutical Policies World Health Organization Geneva, Switzerland scholtenw@who.int
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