Plain language summary pending.
There are few trials that have directly compared the antipyretic properties of paracetamol against placebo or physical methods. Data on adverse events are limited. Establishing standard outcomes will help comparisons between studies and better meta-analysis.
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.
To assess the effects of paracetamol for treating fever in children in relation to fever clearance time, febrile convulsions, and resolution of associated symptoms.
We searched the Cochrane Infectious Diseases Group Specialized Register (May 2004), CENTRAL (The Cochrane Library Issue 2, 2004), MEDLINE (1966 to May 2004), EMBASE (1988 to May 2004), LILACS (May 2004), Science Citation Index (May 2004), and reference lists of articles. We also contacted researchers in the field.
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.
Two reviewers independently extracted data on methods, types of participants, interventions, and outcomes. The meta-analysis was conducted using risk ratio with 95% confidence intervals for discrete variables, and mean differences for continuous outcomes.
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 (risk ratio 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.