Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

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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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibuprofen, dipyrone, acetaminophen

Drug

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

Primary outcomes

Antipyretic efficacy

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.

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.

Secondary outcomes

Adverse Events

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.

All adverse events were recorded.

Sponsors and collaborators

Lead sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 24, 2011
Registry last updated: May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed