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PEDIATRIC ANESTHESIA

The Pharmacokinetics of the Intravenous Formulation of Fentanyl Citrate Administered Orally in Children Undergoing General Anesthesia

Melissa Wheeler, MD^*, Patrick K. Birmingham, MD^*, Ralph A. Lugo, PharmD, Corri L. Heffner, RN^*, and Charles J. Coté, MD^*,

Department of *Anesthesiology and the Pediatrics, Children’s Memorial Hospital, The Feinberg School of Medicine at Northwestern University, Chicago, Illinois, and the University of Utah College of Pharmacy and School of Medicine, Salt Lake City, Utah

Address correspondence and reprint requests to Melissa Wheeler, MD, Department of Pediatric Anesthesiology, #19, Children’s Memorial Hospital, 2300 Children’s Plaza, Chicago, IL 60614. Address email to mwheeler{at}northwestern.edu

The bioavailability of oral transmucosal fentanyl citrate (OTFC) in children is similar to that of fentanyl solution administered orally to adults. We hypothesized that administering an oral fentanyl solution to children would result in similar fentanyl plasma concentrations and pharmacokinetic variables as administering comparable doses of OTFC. In this pilot study, 10 healthy children requiring postoperative analgesia were enrolled. Each received the undiluted IV fentanyl formulation orally (approximately 10–15 µg/kg; maximum, 400 µg). Venous blood samples were collected from 15 to 600 min after administration. Pharmacokinetic variables were determined using noncompartmental analysis and were compared with a previously studied population of children who received a similar dose of OTFC. Pharmacokinetic variables for the orally administered IV fentanyl formulation were as follows: time to reach peak concentration = 1.7 ± 1.6 h, peak concentration = 1.83 ± 1.19 ng/mL, half-life = 4.7 ± 2.8 h, area under the plasma concentration time curve = 6.46 ± 3.96 h · ng^–1 · mL^–1, apparent oral volume of distribution (V/F) = 17.5 ± 7.2 L/kg, apparent oral clearance (CL/F) = 3.33 ± 2.25 L · kg^–1 · h^–1. Although both OTFC and orally administered IV fentanyl resulted in similar pharmacokinetic variables and plasma concentrations for a given dose, there was marked interpatient variability, particularly in the early hours after oral administration of the IV formulation of fentanyl. This suggests that this method of administration be used with caution until further data are available.

IMPLICATIONS: In this pilot study of 10 children undergoing general anesthesia, we found pharmacokinetic variables and plasma concentrations with the IV formulation of fentanyl given by mouth to be similar to those described for oral transmucosal fentanyl. Further studies of efficacy and safety are required before this method of fentanyl administration can be safely recommended.

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