A randomised controlled trial of combination versus single antipyretic treatment in febrile children

ISRCTN	ISRCTN30487061
DOI	https://doi.org/10.1186/ISRCTN30487061
Protocol serial number	N/A
Sponsor	American University of Beirut (Lebanon)
Funder	American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (ref: DCR 114170-034120)

Submission date: 18/02/2005
Registration date: 23/02/2005
Last edited: 19/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mona Nabulsi
Scientific

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

Phone	+961 (0)3 628528
Email	mn04@aub.edu.lb

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	14 Years
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	26/11/2002
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Lebanon

Study participating centre

American University of Beirut Medical Center

Beirut
113-6044/C8
Lebanon

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	04/03/2006		Yes	No