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A randomised controlled trial of rectal versus oral acetaminophen antipyresis in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11886401
Enrollment
48
Registered
2005-03-10
Start date
2000-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever Signs and Symptoms Fever

Interventions

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 (equival

Sponsors

American University of Beirut (Lebanon)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Time to maximum antipyresis following administration of a single dose of acetaminophen.

Secondary

MeasureTime frame
Secondary outcomes included the temperatures at one, two, three, four, five, and six hours from administration and possible side effects such as hypothermia.

Countries

Lebanon

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026