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PEDIATRICS Vol. 108 No. 4 October 2001, p. e73

ELECTRONIC ARTICLE:
Antipyretic Efficacy of an Initial 30-mg/kg Loading Dose of Acetaminophen Versus a 15-mg/kg Maintenance Dose

Received Jan 16, 2001; accepted Jun 1, 2001.

Jean Marc Tréluyer*, Sylvie Tonnelier*, Philippe d'AthisDagger , Beatrice Leclerc§, Isabelle Jolivet-Landreau§, and Gérard Pons*

From the * Pharmacologie Périnatale et Pédiatrique, Université René Descartes, Groupe Hospitalier Cochin-Saint Vincent de Paul, Paris, France; Dagger  Biostatistique et Informatique Médicale, CHU, Dijon, France; and § Theraplix, Montrouge, France.

Objective.  To compare the antipyretic efficacy of an initial 30-mg/kg acetaminophen loading dose versus a 15-mg/kg maintenance dose.

Methods.  A double-blind, parallel-group, randomized clinical trial was conducted. A total of 121 febrile (rectal temperature between 39°C and 40°C) but otherwise healthy outpatients who were 4 months to 9 years of age and weighed 4 to 26 kg were assigned randomly to 1 of the dose groups: 15 mg/kg (n = 62) and 30 mg/kg (n = 59).

Results.  In an "intention to treat" analysis, the time to obtain a temperature lower than 38.5°C was significantly shorter in the 30-mg/kg than in the 15-mg/kg group (110 ± 94 minutes vs 139 ± 113 minutes). The maximum temperature decrease was significantly higher in the 30-mg/kg than in the 15-mg/kg group (2.3 ± 0.7°C vs 1.7 ± 0.6°C). Duration of rectal temperature below 38.5°C was significantly longer in the 30-mg/kg than in the 15-mg/kg group (250 ± 92 minutes vs 185 ± 121 minutes, respectively). Adverse events were reported in 6 children in the 30-mg/kg group compared with 5 in the 15-mg/kg group (hyperthermia, hypothermia, vomiting). The difference was not statistically significant.

Conclusion.  An initial 30-mg/kg acetaminophen loading dose seemed to be more effective in reducing fever than a 15-mg/kg maintenance dose. No difference was observed regarding clinical tolerance. These data suggest that acetaminophen treatment of fever may be more efficient in an initial loading dose.  Key words:  fever, loading dose, acetaminophen, children.




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