Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

This study has been completed.
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01359020
First received: May 20, 2011
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Fever
Drug: ibuprofen, dipyrone, acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    All adverse events were recorded.


Enrollment: 396
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359020

Locations
Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
Investigators
Study Director: Claudia Patrícia DN Moura Mantecorp Indústria Química e Farmacêutica Ltda.
  More Information

No publications provided

Responsible Party: Claudia Domingues, Mantecorp
ClinicalTrials.gov Identifier: NCT01359020     History of Changes
Other Study ID Numbers: ALI/P/04-1
Study First Received: May 20, 2011
Last Updated: May 23, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Fever
Ibuprofen
Acetaminophen
Dipyrone

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Dipyrone
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014