A randomised controlled trial of combination versus single antipyretic treatment in febrile childre
Completed
- Conditions
- FeverSigns and Symptoms
- Registration Number
- ISRCTN30487061
- Lead Sponsor
- American University of Beirut (Lebanon)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.<br> 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.