Back to results

Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

Primary Purpose

Fever

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

ibuprofen, dipyrone, acetaminophen

About this trial

This is an interventional treatment trial for Fever focused on measuring Fever, Ibuprofen, Acetaminophen, Dipyrone

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Instituto de Medicina Integral Professor Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Ibuprofen

Acetaminophen

Dipyrone

Arm Description

10 milligram per kilo, oral administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events

All adverse events were recorded.

Full Information

NCT ID

NCT01359020

First Posted

May 20, 2011

Last Updated

May 23, 2011

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01359020

Brief Title

Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fever

Keywords

Fever, Ibuprofen, Acetaminophen, Dipyrone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibuprofen

Arm Type

Experimental

Arm Description

10 milligram per kilo, oral administration

Arm Title

Acetaminophen

Arm Type

Active Comparator

Arm Description

10 milligram per kilo, oral administration

Arm Title

Dipyrone

Arm Type

Active Comparator

Arm Description

10 milligram per kilo, oral administration

Intervention Type

Drug

Intervention Name(s)

ibuprofen, dipyrone, acetaminophen

Intervention Description

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

Primary Outcome Measure Information:

Title

Antipyretic efficacy

Description

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.

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.

Secondary Outcome Measure Information:

Title

Adverse Events

Description

All adverse events were recorded.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia Patrícia DN Moura

Organizational Affiliation

Mantecorp Indústria Química e Farmacêutica Ltda.

Official's Role

Study Director

Facility Information:

Facility Name

Instituto de Medicina Integral Professor Fernando Figueira

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50070-550

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

We'll reach out to this number within 24 hrs