Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Mantercorp

Status and phase: Completed; Phase 4

Conditions: Fever

Treatments: Drug: ibuprofen, dipyrone, acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359020

ALI/P/04-1

Details and patient eligibility

About

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.

Enrollment: 396 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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396 participants in 3 patient groups

Ibuprofen

Experimental group

Description:

10 milligram per kilo, oral administration

Treatment:

Drug: ibuprofen, dipyrone, acetaminophen

Acetaminophen

Active Comparator group

Description:

10 milligram per kilo, oral administration

Treatment:

Drug: ibuprofen, dipyrone, acetaminophen

Dipyrone

Active Comparator group

Description:

10 milligram per kilo, oral administration

Treatment:

Drug: ibuprofen, dipyrone, acetaminophen