OBJECTIVE: To compare the effectiveness and rate of temperature reduction of three antipyretic medications in febrile children. DESIGN: A single-dose, randomised, prospective, modified double-blind, parallel clinical trial. SETTING: The paediatric emergency department of a university hospital that has 13 000 annual visits. STUDY PARTICIPANTS: 252 otherwise healthy children aged 6 months to 14 years with acute, intercurrent, febrile illness. INTERVENTIONS:Enrolled children were assigned to receive a single dose of oral ibuprofen 10 mg/kg, oral nimesulide 2.5 mg/kg, or parenteral dipyrone 10 mg/kg. MAIN OUTCOME MEASURES AND RESULTS:Axillary temperature was measured at the time of antipyretic administration and at 30, 45, 60 and 120 minutes thereafter. All three medications were effective in reducing the axillary temperature during the 2-hour testing period. The rates of axillary temperature change between the three medications were significantly different for the ibuprofen and dipyrone groups (p = 0.023). In addition, the axillary temperature in the dipyrone group was significantly lower than that in the ibuprofen group (p = 0.036) at 120 minutes. There was no significant difference in antipyretic effect between the nimesulide group and the other two groups during the testing period. Within each group the difference between initial temperature and the temperature at the end of the testing period was statistically significant (p = 0.036) for the dipyrone group only. CONCLUSIONS: All three antipyretic medications were effective in reducing the axillary temperature in febrile children. Although administration of intramuscular dipyrone seemed to be more effective than ibuprofen, this relationship was not significant when nimesulide was considered. In addition, in view of its known side effects and the problems associated with intramuscular administration in children, the preference for orally administered nimesulide or ibuprofen over dipyrone in the setting of the emergency department seems more logical provided that the child accepts oral therapy.
RCT Entities:
OBJECTIVE: To compare the effectiveness and rate of temperature reduction of three antipyretic medications in febrile children. DESIGN: A single-dose, randomised, prospective, modified double-blind, parallel clinical trial. SETTING: The paediatric emergency department of a university hospital that has 13 000 annual visits. STUDY PARTICIPANTS: 252 otherwise healthy children aged 6 months to 14 years with acute, intercurrent, febrile illness. INTERVENTIONS: Enrolled children were assigned to receive a single dose of oral ibuprofen 10 mg/kg, oral nimesulide 2.5 mg/kg, or parenteral dipyrone 10 mg/kg. MAIN OUTCOME MEASURES AND RESULTS: Axillary temperature was measured at the time of antipyretic administration and at 30, 45, 60 and 120 minutes thereafter. All three medications were effective in reducing the axillary temperature during the 2-hour testing period. The rates of axillary temperature change between the three medications were significantly different for the ibuprofen and dipyrone groups (p = 0.023). In addition, the axillary temperature in the dipyrone group was significantly lower than that in the ibuprofen group (p = 0.036) at 120 minutes. There was no significant difference in antipyretic effect between the nimesulide group and the other two groups during the testing period. Within each group the difference between initial temperature and the temperature at the end of the testing period was statistically significant (p = 0.036) for the dipyrone group only. CONCLUSIONS: All three antipyretic medications were effective in reducing the axillary temperature in febrile children. Although administration of intramuscular dipyrone seemed to be more effective than ibuprofen, this relationship was not significant when nimesulide was considered. In addition, in view of its known side effects and the problems associated with intramuscular administration in children, the preference for orally administered nimesulide or ibuprofen over dipyrone in the setting of the emergency department seems more logical provided that the child accepts oral therapy.