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Randomized controlled trial of asthma risk with paracetamol use in infancy--a feasibility study

J Riley1, I Braithwaite, P Shirtcliffe

  • 1Medical Research Institute of New Zealand, Wellington, New Zealand.

Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology
|October 11, 2014
PubMed

Insights

This study explored feasibility for a paracetamol (acetaminophen) and childhood asthma trial. Ibuprofen emerged as the preferred comparator for future randomized controlled trials investigating paracetamol

Area of Science:

  • Pediatric pharmacology
  • Clinical trial methodology
  • Respiratory medicine

Background:

  • Observational studies suggest a link between paracetamol (acetaminophen) use and increased asthma risk in children.
  • Methodological challenges in previous research necessitate a randomized controlled trial (RCT) to confirm this association.
  • Investigating paracetamol's role in childhood asthma requires careful consideration of trial design and comparators.

Purpose of the Study:

  • To assess the feasibility of conducting an RCT examining liberal versus restricted paracetamol (acetaminophen) dosing in infants.
  • To determine parental preferences for comparator treatments, including restricted paracetamol, ibuprofen, or placebo.
  • To establish a suitable comparator for future RCTs on paracetamol use and childhood asthma risk.

Main Methods:

  • A feasibility study involving questionnaires on parental preferences for comparator treatments (ibuprofen, restricted paracetamol, placebo).
  • Infants with bronchiolitis were randomized to either a restricted or liberal paracetamol dosing regimen for three months.
  • Paracetamol consumption was recorded through parental reporting and direct measurement.

Main Results:

  • Parental acceptance rates varied: ibuprofen (58%), restricted paracetamol (40%), and placebo (12%).
  • A significant difference in paracetamol dosing was achieved between the liberal (median reported use 2.0-fold higher) and restricted groups (median measured use 3.5-fold higher).
  • The study successfully randomized 30% of eligible infants to the paracetamol dosing arms.

Conclusions:

  • A liberal versus restricted paracetamol regimen can effectively create dosing separation for an RCT.
  • Ibuprofen is identified as the most suitable comparator for future RCTs investigating the relationship between paracetamol use and childhood asthma.
  • This feasibility study provides crucial insights for designing a definitive RCT on paracetamol and asthma risk.
Abstract

Keywords:
acetaminophenasthmabronchiolitiscomparator armfeasibilityinfantsparacetamol

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