OBJECTIVE: To compare the antipyretic efficacy of ibuprofen syrup (5 mg/kg per dose) and acetaminophen syrup (10 mg/kg per dose) in children with a history of febrile seizures. DESIGN: Randomized, multiple-dose, double-blind, cross-over trial. SETTING: The outpatient department of a university-affiliated teaching hospital. PATIENTS: Seventy outpatients (mean age, 2.1 years; range, 10 months to 4 years) who had visited the hospital because of a febrile seizure were randomized to treatment at a temperature of 38.5 degrees C or higher. INTERVENTIONS: Study medication was given every 6 hours for 1 to 3 days. Rectal temperatures were recorded at 0, 2, 4, 6, 12, and 24 hours after the first dose. MAIN OUTCOME MEASURES: The temperature 4 hours after the first dose, the mean temperature during treatment, and the highest temperature during treatment were evaluated. Analysis of covariance corrected for the initial temperature, age, weight, and cause of the fever. RESULTS:Ibuprofen lowered the initial temperature from 39.1 degrees C to a mean temperature of 37.7 degrees C during treatment; acetaminophen lowered the initial temperature from 39.2 degrees C to 38.0 degrees C. Ibuprofen reduced fever 0.50 degree C more than did acetaminophen at 4 hours (95% confidence interval [CI], -0.98 to -0.02). The mean temperature was 0.26 degree C lower during ibuprofen treatment (95% CI, -0.59 to 0.07); the highest temperature was 0.30 degree C lower (95% CI, -0.73 to 0.13). In 22 patients, a second fever was treated with the opposite medication than the first. In the cross-over analysis, the respective differences were 0.66 degree C (95% CI, -1.29 to -0.06), 0.40 degree C (95% CI, -0.83 to 0.03), and 0.36 degree C (95% CI, -0.81 to 0.08) in favor of ibuprofen. CONCLUSIONS:Ibuprofen and acetaminophen are effective antipyretic agents in children with a history of febrile seizures. Ibuprofen yielded significantly greater fever reduction than did acetaminophen 4 hours after the first dose. Research is needed on the value of antipyretic agents for the prevention of febrile seizure recurrence.
RCT Entities:
OBJECTIVE: To compare the antipyretic efficacy of ibuprofen syrup (5 mg/kg per dose) and acetaminophen syrup (10 mg/kg per dose) in children with a history of febrile seizures. DESIGN: Randomized, multiple-dose, double-blind, cross-over trial. SETTING: The outpatient department of a university-affiliated teaching hospital. PATIENTS: Seventy outpatients (mean age, 2.1 years; range, 10 months to 4 years) who had visited the hospital because of a febrile seizure were randomized to treatment at a temperature of 38.5 degrees C or higher. INTERVENTIONS: Study medication was given every 6 hours for 1 to 3 days. Rectal temperatures were recorded at 0, 2, 4, 6, 12, and 24 hours after the first dose. MAIN OUTCOME MEASURES: The temperature 4 hours after the first dose, the mean temperature during treatment, and the highest temperature during treatment were evaluated. Analysis of covariance corrected for the initial temperature, age, weight, and cause of the fever. RESULTS:Ibuprofen lowered the initial temperature from 39.1 degrees C to a mean temperature of 37.7 degrees C during treatment; acetaminophen lowered the initial temperature from 39.2 degrees C to 38.0 degrees C. Ibuprofen reduced fever 0.50 degree C more than did acetaminophen at 4 hours (95% confidence interval [CI], -0.98 to -0.02). The mean temperature was 0.26 degree C lower during ibuprofen treatment (95% CI, -0.59 to 0.07); the highest temperature was 0.30 degree C lower (95% CI, -0.73 to 0.13). In 22 patients, a second fever was treated with the opposite medication than the first. In the cross-over analysis, the respective differences were 0.66 degree C (95% CI, -1.29 to -0.06), 0.40 degree C (95% CI, -0.83 to 0.03), and 0.36 degree C (95% CI, -0.81 to 0.08) in favor of ibuprofen. CONCLUSIONS:Ibuprofen and acetaminophen are effective antipyretic agents in children with a history of febrile seizures. Ibuprofen yielded significantly greater fever reduction than did acetaminophen 4 hours after the first dose. Research is needed on the value of antipyretic agents for the prevention of febrile seizure recurrence.