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
1 other identifier
interventional
396
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedMay 24, 2011
May 1, 2011
1.2 years
May 20, 2011
May 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse Events
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.
Study Arms (3)
Ibuprofen
EXPERIMENTAL10 milligram per kilo, oral administration
Acetaminophen
ACTIVE COMPARATOR10 milligram per kilo, oral administration
Dipyrone
ACTIVE COMPARATOR10 milligram per kilo, oral administration
Interventions
The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration
Eligibility Criteria
You may qualify if:
- male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudia Patrícia DN Moura
Mantecorp Indústria Química e Farmacêutica Ltda.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 24, 2011
Study Start
January 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
May 24, 2011
Record last verified: 2011-05