Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359020
• Other study ID #: ALI/P/04-1
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2011
• Last updated: May 23, 2011
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2011
• Source: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• ibuprofen, dipyrone, acetaminophen
The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Mantecorp Industria Quimica e Farmaceutica Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antipyretic efficacy	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.	Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.	No
Secondary	Adverse Events	All adverse events were recorded.	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.	Yes