Condition category
Signs and Symptoms
Date applied
18/02/2005
Date assigned
23/02/2005
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mona Nabulsi

ORCID ID

Contact details

American University of Beirut Medical Center
Beirut
113-6044/C8
Lebanon
+961 (0)3 628528
mn04@aub.edu.lb

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Our study hypothesis is that combined antipyretic therapy (a single dose of 10 mg/kg ibuprofen followed by a single dose of 15 mg/kg of acetaminophen after 4 hours) is more effective than ibuprofen (10 mg/kg) followed by placebo, in reducing the temperature of children with high fever.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Fever

Intervention

1. Experimental group: A single dose (10 mg/kg) of Ibuprofen at zero time, followed by a single dose (15 mg/kg) of Acetaminophen at time = 4 hours
2. Control group: A single dose (10 mg/kg) of Ibuprofen at time zero, followed by a single dose (15 mg/kg) of Placebo at time = 4 hours
3. Rectal temperature recordings at baseline and at time = 4, 5, 6, 7 and 8 hours

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary endpoint of this study is the proportion of children in each group, with body temperature of 37.8°C or less at time 6 hours.

Secondary outcome measures

Secondary endpoints include the proportion of children in each group, with body temperarures of 37.8°C and below, at times 7 and 8 hours, and the change in hourly temperature from baseline, at times 4, 5, 6, 7, 8 hours.
The proportion of patients in each group with any immediate adverse effect (within 24 hours from administration) that may be related to either drug, such as gastrointestinal bleed, hypothermia or others.

Overall trial start date

26/11/2002

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 6 months and 14 years
2. Rectal temperature greater than or equal to 38.8°C
3. Consent of treating physician
4. Consent of parent(s) and child if old enough to give consent (greater than 7 years)
5. No antipyretic intake for 8 hours prior to enrolment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Presence of concurrent hepatic or renal disease
2. Chronic and/or serious disease such as malignancy, septic shock, malabsorption syndromes etc.
3. Any condition that may interfere with the absorption of the investigational drugs such as gastritis, diarrhoea, ileus etc.
4. Hypersensitivity to acetaminophen or ibuprofen
5. Bleeding disorder or tendency
6. Asthma

Recruitment start date

26/11/2002

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Lebanon

Trial participating centre

American University of Beirut Medical Center
Beirut
113-6044/C8
Lebanon

Sponsor information

Organisation

American University of Beirut (Lebanon)

Sponsor details

Faculty of Medicine
Medical Practice Plan
Riyad El-Solh
Beirut
11-02-36
Lebanon
+961 (0)1 350000
resdean@aub.edu.lb

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (ref: DCR 114170-034120)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16515705

Publication citations

  1. Results

    Nabulsi MM, Tamim H, Mahfoud Z, Itani M, Sabra R, Chamseddine F, Mikati M, Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]., BMC Med, 2006, 4, 4, doi: 10.1186/1741-7015-4-4.

Additional files

Editorial Notes