Randomized controlled trial of asthma risk with paracetamol use in infancy – a feasibility study. Issue 2 (February 2015)

• Record Type: Journal Article
• Authors: Riley, J.; Braithwaite, I.; Shirtcliffe, P.; Caswell‐Smith, R.; Hunt, A.; Bowden, V.; Power, S.; Stanley, T.; Crane, J.; Ingham, T.; Weatherall, M.; Mitchell, E. A.; Beasley, R.
• Is Part Of: Clinical & experimental allergy. Volume 45:Issue 2(2015:Feb.)
• Page Start: 448
• Page End: 456
• Publication Date: 2015-02
• Subjects: Allergy -- Periodicals; Immunology -- Periodicals; 616.97
• DOI: 10.1111/cea.12433
• Languages: English
• ISSNs: 0954-7894

Abstract

<abstract abstract-type="main" id="cea12433-abs-0001"> <title>Summary</title> <sec id="cea12433-sec-0001" sec-type="section"> <title>Background</title> <p>There is non‐experimental evidence that paracetamol (acetaminophen) use may increase the risk of developing asthma. However, numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis.</p> </sec> <sec id="cea12433-sec-0002" sec-type="section"> <title>Objective</title> <p>To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator (restricted paracetamol in accordance with WHO guidelines, ibuprofen or placebo), and childhood asthma risk.</p> </sec> <sec id="cea12433-sec-0003" sec-type="section"> <title>Methods</title> <p>Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments. Subsequently, infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded.</p> </sec> <sec id="cea12433-sec-0004" sec-type="section"> <title>Results</title> <p>Of 120 eligible participants, 72 (60%) parents/guardians completed the questionnaire. Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians, respectively. 36 (30%) infants were randomized to restricted or liberal paracetamol. Paracetamol use was greater for the liberal vs. restricted group for reported [Hodges–Lehmann estimator of difference 0.94 mg/kg/day (95% CI 0.2–3.52), <italic>P</italic> = 0.02] and measured use [Hodges–Lehmann estimator of difference 2.11 mg/kg/day (95% CI 0.9–4.18), <italic>P</italic> = 0.004]. The median reported and measured use of paracetamol was 2.0‐fold and 3.5‐fold greater in the liberal vs. restricted group.</p> </sec> <sec id="cea12433-sec-0005" sec-type="section"> <title>Conclusions and Clinical Relevance</title> <p>Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime, ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood.</p> </sec> </abstract>