Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Mantecorp Industria Quimica e Farmaceutica Ltd.396 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

396

Conditions

Fever

Interventions

ibuprofen, dipyrone, acetaminophenDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

Adverse Events

All adverse events were recorded.

Time frame: 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.

Data from ClinicalTrials.gov

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