Condition category
Signs and Symptoms
Date applied
04/03/2005
Date assigned
10/03/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mona Nabulsi

ORCID ID

Contact details

American University of Beirut Medical Center
Beirut
113-6044/C8
Lebanon
+961 (0)3 628528
mn04@aub.edu.lb

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Acetaminophen

Primary outcome measures

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 trial start date

01/11/2000

Overall trial end date

30/09/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

48

Participant 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

Recruitment start date

01/11/2000

Recruitment end date

30/09/2002

Locations

Countries of recruitment

Lebanon

Trial participating centre

American University of Beirut Medical Center
Beirut
113-6044/C8
Lebanon

Sponsor information

Organisation

American University of Beirut (Lebanon)

Sponsor details

Faculty of Medicine
Medical Practice Plan
Riyad El-Solh
Beirut
11-02-36
Lebanon
+961 (0)1 350000
resdean@aub.edu.lb

Sponsor type

University/education

Website

http://www.aub.edu.lb/

Funders

Funder type

University/education

Funder name

American University of Beirut (Lebanon) - Medical Practice Plan of the Faculty of Medicine (grant ref: AUB A/C 686056)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16143048

Publication citations

  1. Results

    Nabulsi M, Tamim H, Sabra R, Mahfoud Z, Malaeb S, Fakih H, Mikati M, Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401]., BMC Pediatr, 2005, 5, 35, doi: 10.1186/1471-2431-5-35.

Additional files

Editorial Notes