Study characterizing the pharmacokinetic (PK) and safety of anesthetics and analgesics used in children and adolescents
Anesthesia and analgesia drugs are commonly used in inpatient and outpatient management of infants, children, and adolescents. Anesthetics (such as ketamine) and analgesics (such as hydromorphone and ketorolac) help alleviate pain and anxiety, and provide adequate conditions for invasive procedures. These benefits account for the substantial increase in the number of anesthetics and analgesics administered to pediatric populations in different clinical settings, for different procedures, and to those of increasingly younger ages. However, many anesthetics and analgesics are not approved by the US Food and Drug Administration for use in children due to inadequate information on drug efficacy, safety, and dosing in pediatric populations. The ANA study aims to explore the PK and safety of both of these drugs in children and adolescents to advise on the best dosing. Approximately 120 children aged 2 to 17 will be enrolled in this study who are already receiving one of the two study drugs as part of their regular care: 60 for ketamine and 60 for hydromorphone.
- Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children The Journal of Clinical Pharmacology • April 2018. Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in ...