Efficacy of ibuprofen in pediatric patients with fever.

We studied the efficacy of ibuprofen in 56 infants and children (age 0.5-12 years) with rectal temperature greater than or equal to 38.3 degrees C, using a double-blind randomized placebo-controlled design. Ibuprofen liquid was given as a single dose, 5 mg/kg to 18 patients (group I) and 10 mg/kg to 18 patients (group II); placebo was administered to 20 patients (group III). Temperature and vital signs were measured every 0.5-1.0 hours for 8 hours. Multiple blood samples were also collected over this period; ibuprofen plasma concentrations were measured by HPLC. The mean temperature was 38.3 degrees C in group I, 38.1 degrees C in group II, and 38.9 degrees C in group III during 8 hours after drug or placebo administration. The temperature was significantly lower in group I vs III (ibuprofen 5 mg/kg vs placebo) (p less than 0.0005), and group II vs III (ibuprofen 10 mg/kg vs placebo) (p less than 0.0001). The temperature was also markedly different for patients in group I vs II (ibuprofen 5 mg/kg vs ibuprofen 10 mg/kg) between 4 and 8 hours after the dose (p less than 0.01). The duration of action was longer for ibuprofen 10 mg/kg than 5 mg/kg. The mean maximum decrease from baseline temperature was 1.3 degrees C, 1.8 degrees C and 0.8 degrees C for group I, II and III, respectively. The maximum reduction in temperature occurred at 3-4 hours in the ibuprofen groups, and at 7 hours in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)