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Population Pharmacokinetics of Oxycodone in Children 6 Months to 7 Years Old

From the Metrum Research Group, Tariffville, Connecticut (Dr El-Tahtawy); the Department of Anesthesiology and Intensive Care, Kuopio University Hospital, Department of Pharmacology and Toxicology, University of Kuopio, Kuopio, Finland (Dr Kokki); and the Departments of Pharmacology and of Pediatrics, Weill Medical College of Cornell University, New York, New York (Dr Reidenberg).

Young children are often undertreated for pain. One barrier to effective pain treatment is understanding the pharmacokinetic behavior of analgesics in this age group. Oxycodone is a commonly prescribed opioid for severe pain, yet little is known about its pharmacokinetics in young children. This article used population pharmacokinetic modeling to synthesize pharmacokinetic data from several studies into a model. A single population model that described the observed pharmacokinetics was developed. The combined data were best described with a 2-compartment linear model with different first-order absorption rates depending on route of administration. Weight was found to significantly influence both clearance (CL) and volume of distribution (Vd). The following model adequately describes the population pharmacokinetic profile of oxycodone where absolute bioavailability (F) is estimated for each administration route: CL/F = 55 x (body weight/70)^0.87; V/F= 86 x (body weight/70)^1.16. The interindividual coefficients of variation in CL and Vd were 20.2 and 19.7%, respectively. This finding confirms that the allometric scaling using the above model explained most of the variability in exposure observed among children. This model confirms using a weight-based dose for oxycodone without adjustment for age between 6 months and 7 years and is valuable for evaluating dosing schedules and dosing routes.

Key Words: Opioid • pediatric • pharmacokinetics

Address for reprints: Bruce E. Reidenberg, MD, Departments of Pharmacology and Pediatrics, Weill Medical College of Cornell University, 1300 York Avenue, New York, NY 10021.