Researchers have completed the first year of analysis in a large-scale clinical trial examining the safety of two common pain relievers in infants. The study, which enrolled nearly 4,000 newborns across New Zealand, randomly assigned half to receive acetaminophen and the other half to receive ibuprofen for fever or pain management during their first year of life.
Parents were regularly surveyed about the development of eczema, asthma symptoms, and bronchiolitis, while researchers also reviewed prescription data and hospital records. The analysis found that approximately 16 percent of infants in the acetaminophen group developed eczema compared with 15 percent in the ibuprofen group. Bronchiolitis occurred in roughly five percent of children in each group, with these differences determined to be statistically insignificant. Serious side effects attributed to either medication were rare.
According to lead researcher Professor Stuart Dalziel of the University of Auckland, the findings provide reassurance to parents and healthcare providers about the safety of these medications, which are among the most widely prescribed and purchased over-the-counter pain relievers for babies globally. The results were published in The Lancet Child & Adolescent Health and represent the first randomized controlled trial to directly examine these questions.
The one-year findings are part of a broader research initiative called PIPPA Tamariki, which is tracking children from birth through age six. The larger study aims to determine whether acetaminophen use in infancy is associated with conditions that become more reliably diagnosable as children age, including asthma, eczema, hay fever, autism, and attention deficit hyperactivity disorder. Additional results are planned for publication when participants reach age three and again at age six.
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