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Randomized Controlled Trial
. 2006 Mar 4:4:4.
doi: 10.1186/1741-7015-4-4.

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]

Mona M Nabulsi  1 , Hala Tamim, Ziyad Mahfoud, Mohammad Itani, Ramzi Sabra, Fadi Chamseddine, Mohammad Mikati
Affiliations
Randomized Controlled Trial

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]

Mona M Nabulsi et al. BMC Med. .

Abstract

Background: Alternating ibuprofen and acetaminophen for the treatment of febrile children is a prevalent practice among physicians and parents, despite the lack of evidence on effectiveness or safety. This randomized, double-blind and placebo-controlled clinical trial aims at comparing the antipyretic effectiveness and safety of a single administration of alternating ibuprofen and acetaminophen doses to that of ibuprofen mono-therapy in febrile children.

Methods: Seventy febrile children were randomly allocated to receive either a single oral dose of 10 mg/kg ibuprofen and 15 mg/kg oral acetaminophen after 4 hours, or a similar dose of ibuprofen and placebo at 4 hours. Rectal temperature was measured at baseline, 4, 5, 6, 7 and 8 hours later. Endpoints included proportions of afebrile children at 6, 7 and 8 hours, maximum decline in temperature, time to recurrence of fever, and change in temperature from baseline at each time point. Intent-to-treat analysis was planned with statistical significance set at P < 0.05.

Results: A higher proportion of subjects in the intervention group (83.3%) became afebrile at 6 hours than in the control group (57.6%); P = 0.018. This difference was accentuated at 7 and 8 hours (P < 0.001) with a significantly longer time to recurrence of fever in the intervention group (mean +/- SD of 7.4 +/- 1.3 versus 5.7 +/- 2.2 hours), P < 0.001. Odds ratios (95%CI) for defervescence were 5.6 (1.3; 23.8), 19.5 (3.5; 108.9) and 15.3 (3.4; 68.3) at 6, 7 and 8 hours respectively. Two-way ANOVA with repeated measures over time revealed a significantly larger decline in temperature in the intervention group at times 7 (P = 0.026) and 8 (P = 0.002) hours.

Conclusion: A single dose of alternating ibuprofen and acetaminophen appears to be a superior antipyretic regimen than ibuprofen mono-therapy. Further studies are needed to confirm these findings.

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Figures

Figure 1
Figure 1
Flow diagram of the subjects' progress through the study.
Figure 2
Figure 2
Mean (SE) change in temperature, from baseline, over time in the two treatment groups.
See this image and copyright information in PMC

References

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