Trial | NCT01359020  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Fever

  • Study Participants

    396
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 Started
Jan 31
2007
Primary Completion
Mar 31
2008
Study Completion
Mar 31
2008
Last Update
May 24
2011
Estimate

Drug ibuprofen, dipyrone, acetaminophen

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

Ibuprofen Experimental

10 milligram per kilo, oral administration

Acetaminophen Active Comparator

10 milligram per kilo, oral administration

Dipyrone Active Comparator

10 milligram per kilo, oral administration

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.
No Results Posted