Clinical question
How effective are paracetamol or ibuprofen, alone or combined, compared with placebo or no treatment in relieving pain in children with acute otitis media (AOM)?
Bottom line
Despite explicit guideline recommendations on their use, current evidence on the effectiveness of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs), alone or combined, in relieving pain in children with AOM is limited. Low-quality evidence indicates both paracetamol and ibuprofen as monotherapies are more effective than placebo in relieving short-term (48 hours) ear pain in children with AOM (paracetamol NNT* 7; ibuprofen NNT 6). There is insufficient evidence of a difference between ibuprofen and paracetamol in relieving short-term (at 24 hours, 48–72 hours and 4–7 days) ear pain in children with AOM. Data on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone are insufficient to draw any firm conclusions.
*NNT = number needed to treat to benefit 1 individual.
Caveat
This review involved only 3 studies, all with small sample sizes (26–219).
Context
AOM is one of the most common childhood infectious diseases and a significant reason for antibiotic prescriptions in children worldwide. Ear pain is central to children’s and parents’ experience of the illness. As antibiotics provide only marginal benefits, analgesic treatment including paracetamol and NSAIDs is regarded as the cornerstone of AOM management in children.
Cochrane Systematic Review
Sjoukes A et al. Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. Cochrane Reviews, 2016, Issue 12. Art. No.: CD011534.DOI: 10.1002/14651858. CD011534.pub2. This review contains 3 studies involving 327 participants.
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