1006 Efficacy and safety of ibuprofen and paracetamol in children

It is interesting to track the debate and research over the past 10-15 years and to note the ascendency of ibuprofen to status as equivalent if not superior to paracetamol. Until the early 1980’s acetylsalicylic acid/aspirin was the most commonly used analgesic/antipyretic; however its association with Reye’s syndrome resulted in a worldwide move away from the drug. As a result, paracetamol, available in the USA without a prescription since 1960, became the non-narcotic analgesic/antipyretic of choice in children. While ibuprofen was also available as an over-the-counter product, as a result of insufficient clinical experience it was not recommended for children under the age of 2 years. However at this time, in South Africa ibuprofen is sold with package inserts that warn against use in infants below 3 months of age, but the drug is one of a number of non-steroidal anti-inflammatories that is used in neonatal units to treat symptomatic patent ductus arteriosus. Several meta-analyses have appeared over the years from Both Europe and North America, with fairly numbers of research papers available for such analysis. In the latest report which covers adults and children, some 85 English-language studies were included that directly compared ibuprofen and paracetamol: 54 contained efficacy data, 35 covered antipyretic/temperature reduction, and 66 reviewed safety data. Qualitatively, ibuprofen was more efficacious than paracetamol for treatment of pain and fever in adults and children, and the drugs were equally safe. Using the subset of data that allowed quantitative analysis, the authors showed that for children ibuprofen was superior for pain 2 hours post-dose and for fever 4 hours post-dose (Odds Ratios ~0.27 for both). No significant difference between drugs in incidence of adverse effects. (Odds Ratio 0.82). While this particular analysis does not comment on the practice of alternating frequent (e.g. 2 hourly) doses of the two drugs, even though adverse effects after single drugs do not generally appear to be a problem, several authors warn that this should not be done.

Read more:
Paediatr Child Health 1998; 3: 273-4
Annals Pharmacother 2010, www.theannals.com, DOI 10.1345/aph.1M332
Clin Ther 2009; 31: 1826-43