Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children

NCT01359020 Phase 4 COMPLETED

The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children. For the efficacy asses were compared: * the time to start the action; * the action duration; * the difference between the basal temperature and the lower temperature in the study period. For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.

Details

Lead sponsor	Mantecorp Industria Quimica e Farmaceutica Ltd.
Phase	Phase 4
Status	COMPLETED
Enrolment	396
Start date	2007-01
Completion	2008-03

Conditions

• Fever

Interventions

• ibuprofen, dipyrone, acetaminophen

Primary outcomes

• Antipyretic efficacy — Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
  The antipyretic efficacy was assessed comparing the time to the beggining of the action of the drugs, the difference between the final and inicial temperature and time of action.

Countries

Brazil