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ISRCTN
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ISRCTN11886401
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of rectal versus oral acetaminophen antipyresis in children
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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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.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Lebanon
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Disease/condition/study domain
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Fever
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2000
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Anticipated end date
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30/09/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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48
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Interventions
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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.
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Primary outcome measure(s)
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Time to maximum antipyresis following administration of a single dose of acetaminophen.
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Secondary outcome measure(s)
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Secondary outcomes included the temperatures at one, two, three, four, five, and six hours from administration and possible side effects such as hypothermia.
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Sources of funding
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American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (grant ref: AUB A/C 686056)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16143048
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Contact name
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Dr
Mona
Nabulsi
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Address
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American University of Beirut Medical Center
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City/town
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Beirut
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Zip/Postcode
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113-6044/C8
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Country
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Lebanon
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Tel
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+961 (0)3 628528
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Fax
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+961 (0)1 744464
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Email
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mn04@aub.edu.lb
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Sponsor
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American University of Beirut (Lebanon)
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Address
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Faculty of Medicine, Medical Practice Plan
Riyad El-Solh
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City/town
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Beirut
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Zip/Postcode
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11-02-36
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Country
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Lebanon
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Tel
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+961 (0)1 350000
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Fax
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+961 (0)1 744464
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Email
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resdean@aub.edu.lb
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Sponsor website:
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http://www.aub.edu.lb/
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Date applied
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04/03/2005
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Last edited
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20/12/2007
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Date ISRCTN assigned
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10/03/2005
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