Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops 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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Drug: ibuprofen, dipyrone, acetaminophen

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Instituto de Medicina Integral Professor Fernando Figueira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Investigators: Study Director: Claudia Patrícia DN Moura, Mantecorp Industria Quimica e Farmaceutica Ltda.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): May 24, 2011
• Last Update Submitted That Met QC Criteria: May 23, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Fever; Ibuprofen; Acetaminophen; Dipyrone
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen; Dipyrone
• Other Study ID Numbers: ALI/P/04-1