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
-
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.