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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

May 20, 2011
May 23, 2011
January 2007
March 2008   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01359020 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fever
Drug: ibuprofen, dipyrone, acetaminophen
The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration
  • Experimental: Ibuprofen
    10 milligram per kilo, oral administration
    Intervention: Drug: ibuprofen, dipyrone, acetaminophen
  • Active Comparator: Acetaminophen
    10 milligram per kilo, oral administration
    Intervention: Drug: ibuprofen, dipyrone, acetaminophen
  • Active Comparator: Dipyrone
    10 milligram per kilo, oral administration
    Intervention: Drug: ibuprofen, dipyrone, acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
6 Months to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01359020
ALI/P/04-1
Yes
Claudia Domingues, Mantecorp
Mantecorp Industria Quimica e Farmaceutica Ltd.
Not Provided
Study Director: Claudia Patrícia DN Moura Mantecorp Indústria Química e Farmacêutica Ltda.
Mantecorp Industria Quimica e Farmaceutica Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP