Paracetamol versus placebo or physical methods for treating fever in children: Cochrane systematic review

Abstract

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 methods

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.

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 risk ratio with 95% confidence intervals for discrete variables, and 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 (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.

Authors' conclusions

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.

Author(s)

Meremikwu Martin M, Oyo-Ita Angela

Summary

Paracetamol for treating fever in children

Plain language summary pending.

Reviewer's Conclusions

Implications for practice

This systematic review shows that inconsistent and weak evidence supports the use of paracetamol to reduce fever in children. This does not mean that paracetamol is ineffective, but simply that the number of reliable studies evaluating it against placebo or physical methods are too few to be sure it has a therapeutic effect.

In the absence of any obvious harms, a campaign to alter practice is not justifiable. Caregivers and doctors have faith in paracetamol, but its continued use needs to be justified in terms of benefit through future research or the outcome of the related Cochrane Reviews (see description in the 'Background') of the effects of other antipyretic drugs in the management of fever.

Implications for research

We have not demonstrated any convincing direct evidence that paracetamol is effective in reducing fever or preventing febrile convulsions in children. This has the following research implications.

1. Further research in this area warrants larger studies measuring a few simple pragmatic outcomes, such as febrile convulsions; mean time to resolution of fever; and number of participants without fever by one hour.

2. A systematic review of the effects of paracetamol in adults could provide some evidence that clinicians may generalize for all age groups in the interim. Trials including only adults will however not provide any useful information on febrile convulsion since this is a childhood problem.

3. Further reviews of antipyretic drugs need to compare, in the first instance, the drug against placebo. Head to head comparisons against paracetamol presume that paracetamol is the standard treatment.

4. Monitoring of common adverse events and occasional rare events needs to be considered in all evaluations of antipyretic drugs in children.

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