A randomised controlled trial of rectal versus oral acetaminophen antipyresis in children
| ISRCTN | ISRCTN11886401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11886401 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/03/2005
- Registration date
- 10/03/2005
- Last edited
- 20/12/2007
- 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) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | This randomised, double-dummy and placebo controlled study was conducted to compare the antipyretic efficacies of two different rectal doses of acetaminophen: 15 mg/kg and 35 mg/kg to that of a standard oral dose of 15 mg/kg, over a six-hour period, to allow detection of late antipyresis that may occur with rectal acetaminophen. The results of this study will provide further evidence on the comparative antipyretic efficacy of different doses of rectal acetaminophen versus the standard oral one. Our study hypothesis was that a single dose of 15 mg/kg oral acetaminophen is more effective than either 15 mg/kg or 35 mg/kg rectal acetaminophen, in reducing the temperature of febrile children. |
| Ethics approval(s) | The Institutional Review Board and the Ethics Committee at the American University of Beirut, as well as the Board of the Middle East Hospital, approved this study. |
| Health condition(s) or problem(s) studied | Fever |
| Intervention | Group 1: A single dose of oral acetaminophen (15 mg/kg) plus placebo rectal suppository (size equivalent to a 35 mg/kg rectal acetaminophen suppository) Group 2: A single dose of oral placebo (equivalent to a 15 mg/kg oral acetaminophen) plus a rectal suppository containing 15 mg/kg acetaminophen and 20 mg/kg placebo. Group 3: A single dose of oral placebo as in group 2 plus a rectal suppository of 35 mg/kg acetaminophen. Rectal temperature readings at baseline and hourly for a total of 6 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Acetaminophen |
| Primary outcome measure | Time to maximum antipyresis following administration of a single dose of acetaminophen. |
| Secondary outcome measures | Secondary outcomes included the temperatures at one, two, three, four, five, and six hours from administration and possible side effects such as hypothermia. |
| Overall study start date | 01/11/2000 |
| Completion date | 30/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | 1. Age between 6 months and 13 years 2. Rectal temperature greater than or equal to 38.5 °C 3. Consent of treating physician 4. Written consent of parent and oral consent of child if older than 10 years 5. No antipyretic intake for 8 hours prior to enrolment |
| Key exclusion criteria | 1. Presence of concurrent or previous hepatic disease 2. Chronic and/or serious disease such as malignancy, septic shock, malabsorption syndromes etc. 3. Any condition interfering with the absorption of oral or rectal acetaminophen such as vomiting or severe diarrhoea, ileus, rectal bleeding etc. 4. Hypersensitivity to acetaminophen |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 30/09/2002 |
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 | |
| Website | http://www.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 (grant ref: AUB A/C 686056)
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 | 06/09/2005 | Yes | No |
