Ibuprofen did not beat paracetamol in children, and the certainty is low either way

Design

systematic review and random-effects meta-analysis of randomised trials, RoB 2 and GRADE assessed

Population

8 randomised trials, 1,325 children and adolescents with acute mild-to-moderate pain; 3 trials and 196 participants in the primary analysis

Primary outcome

continuous pain score, as standardised mean difference

Effect

SMD -0.28 (95% CI -0.57 to 0.00, P=0.052) favouring ibuprofen; pain freedom RR 1.03 (0.53-1.99); certainty low

Prior meta-analyses drawing on mixed adult and paediatric populations suggested ibuprofen had a modest edge over paracetamol for acute pain in children, and that belief has hardened into practice in many units. This review restricted itself to randomised trials in children under 18, searching to May 2026 and reporting against the PRISMA-Children and Adolescents guideline, with Cochrane RoB 2 and GRADE assessment.

Eight trials with 1,325 participants were included, but only three contributed to the primary continuous pain outcome - 196 analysable children. The pooled standardised mean difference was -0.28 (95% CI -0.57 to 0.00, P=0.052), a small effect favouring ibuprofen that did not reach conventional significance. For pain freedom, two trials in 114 children gave a pooled risk ratio of 1.03 (0.53-1.99). A prespecified sensitivity analysis adding an adult soft-tissue injury trial pulled the estimate towards null (-0.15, -0.38 to 0.09). Certainty of evidence was rated low for both primary outcomes, for imprecision and indirectness.

The practical conclusion is that the choice is yours to make on the patient rather than on the drug. Where the pain has a substantial inflammatory component - a fracture, an injury - ibuprofen remains the more logical choice. Where there is dehydration, renal concern, asthma with known NSAID sensitivity, bleeding risk, or varicella, paracetamol is. And the more important point, which this review does not address, is that either drug given at the right dose and interval will outperform the wrong drug given late and irregularly.

• Choose between ibuprofen and paracetamol on patient factors - inflammation, hydration, renal function, asthma, bleeding risk - not on assumed superiority
• Keep ibuprofen as first choice where the pain is inflammatory, such as fracture or soft tissue injury
• Avoid NSAIDs in the dehydrated child, in varicella, and where there is bleeding or renal concern
• Do not cite ibuprofen superiority as established - the pediatric-only evidence is low certainty and did not reach significance
• Put the effort into dose, interval and regular administration, which matter more than the choice

Why it matters

It removes a preference most units hold as fact, and hands the decision back to the patient in front of you.

Don't overread it

Three trials and 196 children contributed to the primary outcome, at GRADE low certainty - this shows an absence of demonstrated superiority, not demonstrated equivalence.

The statistics, in plain English

A standardised mean difference of -0.28 is a small effect by convention, and its confidence interval touches exactly zero at P=0.052 - which means the data are compatible with no difference at all, and that reading 'nearly significant' as 'probably true' would be a mistake. The more telling detail is that only 3 of 8 trials and 196 of 1,325 participants contributed to that figure; the rest could not be pooled. GRADE low certainty means further research is likely to change the estimate.

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