Clinical Trial: Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Contr

Brief Summary:

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.


Detailed Summary:
Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Current Primary Outcome: Antipyretic efficacy [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events [ Time Frame: Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug. ]

All adverse events were recorded.


Original Secondary Outcome: Same as current

Information By: Mantecorp Industria Quimica e Farmaceutica Ltd.

Dates:
Date Received: May 20, 2011
Date Started: January 2007
Date Completion:
Last Updated: May 23, 2011
Last Verified: May 2011