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Published Online, 12 October 2004, www.theannals.com, DOI 10.1345/aph.1D340.
 The Annals of Pharmacotherapy: Vol. 38, No. 11, pp. 1935-1941. DOI 10.1345/aph.1D340
© 2004 Harvey Whitney Books Company.
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DRUG INFORMATION ROUNDS

Single High-Dose Rectal Acetaminophen in Children

Marie L Varela, PharmD

Assistant Director of Pharmacy, Stony Brook University Hospital, Stony Brook, NY; Clinical Assistant Professor, State University of New York at Stony Brook

Mary Ann Howland, PharmD DABAT FAACT

Clinical Professor of Pharmacy, St. John's University, College of Pharmacy, Jamaica, NY; Consultant, New York City Poison Control Center and Bellevue Hospital's Emergency Department, New York

Reprints: Marie L Varela PharmD, Pharmacy Department, University Hospital, Stony Brook, NY 11794-7310, mvarela{at}notes.cc.sunysb.edu

OBJECTIVE: To determine whether there is sufficient evidence to support the use of one-time high-dose (>30 mg/kg) rectally administered acetaminophen to control postoperative pain in children.

DATA SOURCES: Literature was accessed through MEDLINE (1966–May 2004) and bibliographic searches.

STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all studies regarding the use of greater than 30 mg/kg of acetaminophen in children were included for this review.

DATA SYNTHESIS: A single high dose of rectally administered acetaminophen has been used in children to control postoperative pain. Ten randomized controlled trials and pharmacokinetic studies evaluating the use of greater than 30 mg/kg of rectally administered acetaminophen in children were identified and reviewed. Each study had a unique objective. The studies also differed substantially in regard to design, study population, dosing, rectal formulation used, and monitoring.

CONCLUSIONS: Due to limited study data, wide study variability, and lack of standardization in terms of design, objectives, study population, dosing, rectal formulation, and monitoring, compounded by the fact that children often require additional doses of acetaminophen to control postoperative pain, the practice of using one-time, high-dose, rectally administered acetaminophen in children cannot be recommended at this time.

Key Words: acetaminophen, children, rectal administration

Published Online, October 12, 2004. www.theannals.com, DOI 10.1345/aph.1D340




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