Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: A randomized controlled trial

Context and Objective: Dipyrone is a widely used over-the-counter antipyretic in Latin America, and elsewhere among Latin immigrants. Despite limited evidence, physicians often prescribe oral ibuprofen or intramuscular dipyrone as the most effective antipyretics. Our aim was to compare the antipyretic efficacy and tolerability of a single dose of oral ibuprofen, oral dipyrone or intramuscular dipyrone in febrile children. Design and Setting: Randomized, single-blind clinical trial, at San Bartolomé Mother-Child National Teaching Hospital, Lima, Peru. Methods: Children from six months to six years old with fever (rectal temperature: 38.3 to 39.8° C) in the emergency word between February and June 2003 were eligible. Seventy-five children were randomly assigned to receive a single-dose of oral ibuprofen (10 mg/kg), oral dipyrone (15 mg/kg) or intramuscular dipyrone (15 mg/kg). The primary outcome was mean temperature reduction after 30, 45, 60, and 120 minutes. Secondary outcomes were fever-associated symptoms and clinical adverse events. Results: Fever decreased by about 0.5° C after 45 minutes and by about 1.0° C after 120 minutes in all three groups. Mean temperatures were similar for the three groups at all times. There was a significant decrease in fever-associated symptoms for all groups. Six patients (four receiving oral dipyrone and two receiving ibuprofen) were withdrawn because of vomiting within 20 minutes after first dose of study medication. One patient assigned to oral ibuprofen presented transient urticaria. Conclusions: Antipyretic efficacy and tolerability were similar for oral ibuprofen, oral dipyrone and intramuscular dipyrone. Oral antipyretics seem more appropriate for feverish children.