A2.2.2 Paracetamol versus non-steroidal anti-inflammatory drugs
Clinical question In children with persisting pain due to medical illnesses, should paracetamol as compared to NSAIDs be used at step one of a two- or three-step approach?
Recommendations 2. Paracetamol and ibuprofen are the medicines of choice in the first step (mild pain). -- The panel opted not to recommend either paracetamol or ibuprofen in preference to one another. Both these medicines have a place in the first step of the two-step analgesic approach. 3. Both paracetamol and ibuprofen need to be made available for treatment in the first step. Strong recommendations, low quality of evidence
Domains and considerations
Quality of evidence There is evidence for the superiority of the analgesic properties of ibuprofen versus paracetamol but only for acute pain (Annex 4. Evidence retrieval and appraisal, GRADE Table 1A and other studies in Annex 4 comparing paracetamol versus ibuprofen). This was considered low-quality evidence based on the indirectness of the condition treated and the absence of long-term safety evidence. No evidence for the safety and efficacy of other NSAIDs other than ibuprofen was found. Uncertainty: yes, due to the lack of comparative long-term safety data.
Risks/benefits Benefits The panel recognized the widely-held clinical view that NSAIDs and paracetamol are indicated in different pain conditions. However, no direct evidence for this approach was identified or retrieved. Risks The long-term safety of both paracetamol and NSAIDs in children is unknown. There are concerns about potential renal and gastrointestinal toxicity and bleeding with NSAIDs. There are well-described risks of acute overdose associated with paracetamol. There is age restriction in the use of ibuprofen below three months of age. Uncertainty: yes, in relation to long-term safety data and to comparative safety data with NSAIDs other than ibuprofen.
Values and acceptability In favour The panel places high value on having the two alternatives (paracetamol and ibuprofen). Against None. Uncertainty: none.
Cost Both paracetamol and ibuprofen are widely available and relatively inexpensive. Child-appropriate dosage forms – such as liquid oral forms – exist, but divisible dispersible oral solid dosage forms are still needed. Uncertainty: none.
> 86 Feasibility No problem with feasibility is anticipated. Uncertainty: none. A1
Policy and research agenda Child-appropriate dosage forms exist for both paracetamol and ibuprofen, but the development of divisible dispersible oral solid dosage forms should be prioritized. Long-term safety data for NSAIDs and paracetamol in the paediatric population are needed. A2
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