Background: Paracetamol (acetaminophen) is widely used for treating fever in children. Like ibuprofen, aspirin, and physical methods (such as fanning), paracetamol aims to provide relief from symptoms and prevent febrile convulsions. Uncertainty exists about the benefits of using it to treat fever in children.
Objectives: To assess the effects of paracetamol for treating fever in children in relation to fever clearance time, febrile convulsions, and resolution of associated symptoms.
Search strategy: We searched the Cochrane Infectious Diseases Group specialized trials register (November 2001), The Cochrane Controlled Trials Register (The Cochrane Library Issue 4, 2001), MEDLINE (1966 to November 2001), EMBASE (1988 to November 2001), LILACS (2001, 40a Edition CD-ROM), Science Citation Index (November 2001), and reference lists of articles. We also contacted researchers in the field.
Selection criteria: Randomized and quasi-randomized trials of children with fever from infections comparing: (1) paracetamol with placebo or no treatment; and (2) paracetamol with physical cooling methods (eg, sponging, bathing, or fanning). The primary outcomes were fever clearance time and febrile convulsion.
Data collection and analysis: Two reviewers independently extracted data on methods, types of participants, interventions, and outcomes. The meta-analysis was conducted using Relative Risk with 95% confidence intervals for discrete variables, and weighted mean differences for continuous outcomes.
Main results: 12 trials (n = 1509 participants) met the inclusion criteria. Outcomes varied between trials. No data were available on the primary outcome. There is insufficient evidence to show whether paracetamol influenced the risk of febrile convulsions. In a meta-analysis of two trials (n = 120), the proportion of children without fever by the second hour after treatment did not differ significantly between those given paracetamol and those sponged (Relative Risk 1.84; confidence interval 0.94 to 3.61, random effects model). The statistical test showed significant heterogeneity between the groups receiving paracetamol or physical methods. No severe adverse events were reported. The number of children with mild adverse events did not differ significantly between paracetamol and placebo, or paracetamol and physical methods, but numbers were small.
Reviewer's conclusions: Trial evidence that paracetamol has a superior antipyretic effect than placebo is inconclusive. There is limited evidence that there is no difference between the antipyretic effect of paracetamol and physical methods. Data on adverse events in these trials were limited. Establishing standard outcomes will help comparisons between studies and meta-analysis.