Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Phase 4

Completed

• Conditions: Fever
• Interventions: Drug: ibuprofen, dipyrone, acetaminophen

• Registration Number: NCT01359020
• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-23
• Last Update Submitted: 2011-05-23
• Study First Posted: 2011-05-24
• Last Update Posted: 2011-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	ibuprofen, dipyrone, acetaminophen	10 milligram per kilo, oral administration
Acetaminophen	ibuprofen, dipyrone, acetaminophen	10 milligram per kilo, oral administration
Dipyrone	ibuprofen, dipyrone, acetaminophen	10 milligram per kilo, oral administration

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	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.

Trial Locations

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil