Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibuprofen

10 milligram per kilo, oral administration

Group Type EXPERIMENTAL

ibuprofen, dipyrone, acetaminophen

Intervention Type DRUG

The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration

Acetaminophen

10 milligram per kilo, oral administration

Group Type ACTIVE_COMPARATOR

ibuprofen, dipyrone, acetaminophen

Intervention Type DRUG

The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration

Dipyrone

10 milligram per kilo, oral administration

Group Type ACTIVE_COMPARATOR

ibuprofen, dipyrone, acetaminophen

Intervention Type DRUG

The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration

Interventions

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ibuprofen, dipyrone, acetaminophen

The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No