External Validation of a Recently Developed Population Pharmacokinetic Model for XXXX During Postoperative Pain Therapy.

@entity1 @entity282 @entity10748 @entity2246
BACKGROUND AND OBJECTIVE: We recently developed a new population pharmacokinetic model for @entity10748 in @entity1 including age and bodyweight as covariates. The aim of the present study was to evaluate prospectively the predictive performance of this new model during @entity282 therapy. METHODS: This was a prospective, single-blinded, randomized, single-center study with two parallel arms. Fifty @entity1 aged 40-85  years undergoing cardiac surgery involving thoracotomy were enrolled. @entity10748 was administered postoperatively on the intensive care unit as target controlled infusion (TCI) for @entity1 controlled analgesia (TCI-PCA) using the new pharmacokinetic model, or as conventional @entity1 controlled analgesia (PCA). Arterial blood samples were taken for measurement of the @entity10748 plasma concentration. The predictive performance of the pharmacokinetic model was assessed by the @entity2246 ( @entity2246 ), the median absolute performance error (MDAPE), wobble and divergence. For comparison, the performance indices were also determined for three older models from the literature. RESULTS: 903 plasma concentrations of 41 @entity1 were analyzed. The mean values (95  % CI) of @entity2246 , MDAPE, wobble and divergence for the new pharmacokinetic model were 11.2  % (3.9 to 18.7  %), 28.5  % (23.9 to 33.0  %), 21.4  % (18.0 to 24.9  %) and -1.6  %/h (-2.3 to -0.8  %/h). When compared with older models from the literature, performance was better with less overshoot after bolus doses. CONCLUSION: The new pharmacokinetic model of @entity10748 showed a good precision and a better performance than older models. It is therefore suitable for TCI with @entity10748 during @entity282 therapy. TRIAL REGISTRATION: EudraCT 2013-002875-16, Clinical Trials NCT02035709.
