Limited evidence for paracetamol and/or NSAIDs in acute otitis media

Paracetamol and ibuprofen as monotherapies may be more effective than placebo in relieving pain at 48 hours. For paracetamol versus placebo, the proportion of children with pain was 10% versus 25% (relative risk 0.38; 95% confidence interval 0.17–0.85; number needed to treat to benefit 7; low-certainty evidence). For ibuprofen versus placebo, the proportion of children with pain was 7% versus 25% (RR 0.28; 95% CI 0.11–0.70; NNTB 6; low-certainty evidence).

The evidence is very uncertain for the effectiveness of ibuprofen versus paracetamol in relieving pain in children with AOM, as well as for ibuprofen plus paracetamol versus paracetamol alone, thereby preventing any firm conclusions.

Adverse events occurred infrequently, and limited data were available for analysis. The evidence for the effects of paracetamol and ibuprofen, alone or combined, on adverse events is very uncertain.