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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359020

Enrollment

396

Registered

2011-05-24

Start date

2007-01-31

Completion date

2008-03-31

Last updated

2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Keywords

Fever, Ibuprofen, Acetaminophen, Dipyrone

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.

Interventions

DRUGibuprofen, dipyrone, acetaminophen

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Antipyretic efficacy	Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.	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

Measure	Time frame	Description
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.	All adverse events were recorded.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026