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Efficacy of ibuprofen in pediatric patients with fever
M C Nahata1, D A Powell, D E Durrell
1College of Pharmacy, Ohio State University, Columbus.
Insights
Ibuprofen effectively reduced fever in children, with a 10 mg/kg dose showing a greater and longer-lasting effect than a 5 mg/kg dose compared to placebo. This study highlights ibuprofen
Area of Science:
- Pediatric Pharmacology
- Clinical Therapeutics
- Pharmacokinetics
Background:
- Fever management in infants and children is a common clinical challenge.
- Ibuprofen is a widely used antipyretic agent, but optimal dosing for pediatric populations requires further investigation.
Purpose of the Study:
- To evaluate the efficacy and dose-response relationship of ibuprofen in reducing fever in pediatric patients.
- To compare the antipyretic effects of two different ibuprofen doses (5 mg/kg and 10 mg/kg) against a placebo.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 56 children aged 0.5-12 years with fever (rectal temperature ≥38.3°C).
- Participants received a single dose of ibuprofen (5 mg/kg or 10 mg/kg) or placebo.
- Temperature, vital signs, and ibuprofen plasma concentrations (via HPLC) were monitored for 8 hours.
Main Results:
- Both ibuprofen doses significantly reduced temperature compared to placebo (p < 0.0005 for 5 mg/kg, p < 0.0001 for 10 mg/kg).
- The 10 mg/kg dose resulted in a greater maximum temperature reduction (1.8°C vs 1.3°C) and a longer duration of action than the 5 mg/kg dose.
- Maximum temperature reduction occurred earlier with ibuprofen (3-4 hours) compared to placebo (7 hours).
Conclusions:
- Ibuprofen is an effective antipyretic in children.
- The 10 mg/kg dose of ibuprofen demonstrates superior efficacy and duration of action compared to the 5 mg/kg dose for fever reduction in pediatric patients.
Abstract:
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)
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