The quality of evidence is downgraded by study limitations (unclear allocation concealment) and by indirectness (differences between the interventions of interest and those studied).
A Cochrane review included 3 studies with a total of 327 children with acute otitis media (AOM). One study compared paracetamol 10 mg/kg versus ibuprofen 10 mg/kg versus placebo orally 3 times daily for 48 hours in 219 children with AOM. Children received concurrent antibiotic therapy (cefaclor) and those with fever > 39 °C could have received paracetamol (30 mg to 60 mg) in addition to the studied treatments. Authors of 2 studies comparing paracetamol versus ibuprofen versus paracetamol plus ibuprofen in children with fever and patients with respiratory tract infections provided crude subgroup data on children with AOM (26 and 82 children, respectively).
| Comparison | Relative effect (95% CI) | Assumed risk - Placebo | Corresponding risk – Intervention (95% CI) | NNTB | Participnats (studies) |
|---|---|---|---|---|---|
| NNTB=number needed to treat to benefit | |||||
| Outcome: Pain at 48 hours | |||||
| Paracetamol vs. placebo | RR 0.38 (0.17 to 0.85) | 253 per 1000 | 96 per 1000 (43 to 215) | 7 | 148 (1 study) |
| Ibuprofen vs. placebo | RR 0.28 (0.11 to 0.70) | 253 per 1000 | 71 per 1000 (28 to 177) | 6 | 146 (1 study) |
Both paracetamol and ibuprofen as monotherapies were more effective than placebo in relieving pain at 48 hours (table ). Adverse events did not significantly differ between paracetamol (RR 1.03, 95% CI 0.21 to 4.93; 1 study, n=148) or ibuprofen (RR 1.76, 95% CI 0.44 to 7.10; 1 study, n=146) compared to placebo.
There was no difference between ibuprofen and paracetamol in relieving ear pain at 24 hours (RR 0.83, 95% CI 0.59 to 1.18; 2 studies, n=39), 48 to 72 hours (RR 0.91, 95% CI 0.54 to 1.54; 3 studies, n=183) and 4 to 7 days (RR 0.74, 95% CI 0.17 to 3.23; 2 studies, n=38).
Data on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone came from 2 studies that provided crude subgroup data for 71 children with AOM. The small sample provided imprecise effect estimates and it was not possible to draw any firm conclusions.