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PEDIATRIC ANESTHESIA

The Pharmacokinetics of Epidural Ropivacaine in Infants and Young Children

Mary Ellen McCann, MD^*, Navil F. Sethna, MD ChB^*, Jean-Xavier Mazoit, MD PhD, Masayuki Sakamoto, BS, Nader Rifai, PhD, Todd Hope, BA, Lorna Sullivan, RN^*, Susan G. Auble, BSN JD^*, and Charles B. Berde, MD PhD^*

Departments of *Anesthesia and Laboratory Science, Children’s Hospital and Harvard Medical School, Boston, Massachusetts; and Laboratoire d’Anesthesie Universite Paris-Sud, Le Kremlin-Bicetre, France

Address correspondences and reprint requests to Mary Ellen McCann, MD, Department of Anesthesia, Children’s Hospital, 300 Longwood Ave., Boston, MA 02115. Address e-mail to McCann_M{at}tch.harvard.edu

The pharmacokinetic variables of ropivacaine were characterized after epidural bolus injection in pediatric patients. The subjects, 7 infants (aged 3–11 mo) and 11 young children (aged 12–48 mo), received 1.7 mg/kg of ropivacaine via a lumbar epidural catheter. Total plasma concentrations of ropivacaine measured over 24 h were assayed by high-pressure liquid chromatography, and pharmacokinetic modeling was performed by Nonlinear Mixed Effects Modeling analysis. The median peak venous plasma concentrations (C_max) in infants and young children were 610 µg/L (interquartile range [IQR], 550–725 µg/L) and 640 µg/L (IQR, 540–750 µg/L), respectively. The median times to maximum plasma ropivacaine concentration (T_max) were 60 min (IQR, 60–120 min) in infants and 60 min (IQR, 30–90 min) in young children. There were no statistical differences between median values of C_max and T_max between infants and young children. The calculated clearance (CL) in infants was 4.26 mL · min^-1 · kg^-1 (9% coefficient of variation), and in young children it was 6.15 mL · min^-1 · kg^-1 (11% coefficient of variation). The CL for infants was significantly less than the CL for young children (P < 0.01). The volume of distribution was estimated to be 2370 mL/kg (9% coefficient of variation) for both young children and infants. No systemic toxicity was observed in either group.

IMPLICATIONS: This study revealed that the pharmacokinetic variables of lumbar epidural bolus ropivacaine in pediatric patients aged 3 to 48 mo are similar to those of adults, except that drug clearance was less in infants compared with older children.

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