A randomised controlled trial of combination versus single antipyretic treatment in febrile children
| ISRCTN | ISRCTN30487061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30487061 |
| Secondary identifying numbers | N/A |
- 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
Scientific
American University of Beirut Medical Center
Beirut
113-6044/C8
Lebanon
| Phone | +961 (0)3 628528 |
|---|---|
| mn04@aub.edu.lb |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 26/11/2002 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 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
113-6044/C8
Lebanon
Sponsor information
American University of Beirut (Lebanon)
University/education
University/education
Faculty of Medicine, Medical Practice Plan
Riyad El-Solh
Beirut
11-02-36
Lebanon
| Phone | +961 (0)1 350000 |
|---|---|
| resdean@aub.edu.lb | |
"ROR" |
https://ror.org/04pznsd21 |
Funders
Funder type
University/education
American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (ref: DCR 114170-034120)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
