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A randomised controlled trial of combination versus single antipyretic treatment in febrile children
DOI 10.1186/ISRCTN30487061
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of combination versus single antipyretic treatment in febrile children
Scientific title
Acronym N/A
Serial number at source N/A
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Lebanon
Disease/condition/study domain Fever
Participants - 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
Participants - 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
Anticipated start date 26/11/2002
Anticipated end date 30/06/2005
Status of trial Completed
Patient information material
Target number of participants 160
Interventions 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
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.
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.
Sources of funding American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (ref: DCR 114170-034120)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16515705
Contact name Dr  Mona  Nabulsi
  Address American University of Beirut Medical Center
  City/town Beirut
  Zip/Postcode 113-6044/C8
  Country Lebanon
  Tel +961 (0)3 628528
  Fax +961 (0)1 744464
  Email mn04@aub.edu.lb
Sponsor American University of Beirut (Lebanon)
  Address Faculty of Medicine, Medical Practice Plan
Riyad El-Solh
  City/town Beirut
  Zip/Postcode 11-02-36
  Country Lebanon
  Tel +961 (0)1 350000
  Fax +961 (0)1 744464
  Email resdean@aub.edu.lb
Date applied 18/02/2005
Last edited 19/02/2008
Date ISRCTN assigned 23/02/2005
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