RCT Abstract - Paracetamol compared to ibuprofen as required for pain or fever: One-year outcomes for eczema and bronchiolitis in the PIPPA Tamariki RCT

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Background In non-experimental studies early-life exposure to paracetamol is associated with increased risks of childhood eczema and wheeze. Objective To compare paracetamol to ibuprofen as required for fever and pain in the first year, for the incidence of eczema and bronchiolitis at one year of age. Methods Multicentre, open-label, two-arm, parallel-groups, superiority RCT randomising infants aged <8 weeks of age, stratified by recruitment site, maternal asthma status and multiple birth, to only paracetamol (15mg/kg) or only ibuprofen (<3 months: 5mg/kg; ≥3 months: 10mg/kg), as required for fever and pain, until one year of age. Eczema was defined by UK Diagnostic Criteria or eczema hospitalisation. Bronchiolitis was defined by at least one relevant hospitalisation. Risk differences (RD) and odds ratios (OR), were estimated. The latter adjusted for cluster randomisation and stratification variables. Results From April 2018 to July 2023, 3923 infants were enrolled and 3908 infants had analysis data. Eczema occurred in 322/1985 (16.2%) in the paracetamol, and 296/1923 (15.4%) in the ibuprofen group: RD (95% CI) 0.8% (-1.5 to 3.1), P=0.48. The adjusted OR (95% CI) was 1.10 (0.92 to 1.32), P=0.29. Bronchiolitis occurred in 98/1985 (4.9%) in the paracetamol, and in 82/1923 (4.3%) in the ibuprofen group: RD (95% CI) 0.7% (-0.6 to 2.0), P=0.32. The adjusted OR (95% CI) was 1.17 (0.75 to 1.85), P=0.21. 17 participants had serious adverse events (paracetamol 8; ibuprofen 9); none were thought to be due to the study drug. Conclusion There was no evidence of a difference in eczema or bronchiolitis at age one year comparing paracetamol with ibuprofen.

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