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Evaluation of Sigmoidal Maturation and Allometric Models: Prediction of Propofol Clearance in Neonates and Infants

Mahmood, Iftekhar PhD*

doi: 10.1097/MJT.0b013e318237356f
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The main objectives of this report are to predict propofol clearance in neonates and infants by a maturation model that includes age and weight and to compare the predictive performance of propofol maturation model with a simple allometric model (clearance vs. body weight). Age, weight, and propofol clearance data were obtained from the literature. A maturation model for propofol was developed using data from neonates, toddlers, children, adolescents, and adults (N = 71). The allometric model was developed using the same data as the maturation model. The predicted clearance of propofol in an individual neonate or infant from these models was compared with the observed clearance (16 neonates and 22 infants) in that individual neonate or infant. The prediction of propofol clearance in most of the individual neonates or infants by both maturation and allometric models was poor. However, the mean predicted propofol clearance in the neonates by both models was comparable with the observed clearance, but the mean predicted propofol clearance in the infants was underpredicted by both models. The propofol maturation and simple allometric model performed poorly for the prediction of propofol clearance in individual neonate and infant.

From the Office of Blood Review & Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD.

The views expressed in this article are those of the author and do not reflect the official policy of the Food and Drug Administration. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.

The author has no conflicts of interest to disclose.

*Address for correspondence: Office of Blood Review & Research, Center for Biologic Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852. E-mail: iftekhar.mahmood@fda.hhs.gov

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