Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Study Overview
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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.

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

Conditions
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Fever

Intervention / Treatment
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* Drug: ibuprofen, dipyrone, acetaminophen


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>10 milligram per kilo, oral administration | Drug: ibuprofen, dipyrone, acetaminophen<br>* The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration<br>|
| Active Comparator: Acetaminophen<br>10 milligram per kilo, oral administration | Drug: ibuprofen, dipyrone, acetaminophen<br>* The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration<br>|
| Active Comparator: Dipyrone<br>10 milligram per kilo, oral administration | Drug: ibuprofen, dipyrone, acetaminophen<br>* The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever, Ibuprofen, Acetaminophen, Dipyrone