Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Treatments: Acetaminophen; Dipyrone; Ibuprofen

Criteria

Inclusion Criteria:

• male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.

Exclusion Criteria:

• patients with a bad general heath state

• patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;

• intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;

• moderated or severe dehydration;

• conscience state alteration;

• not capable of ingest oral drugs;

• patients being treated with steroids;

• patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.