Anesthesia and Analgesics in Children (ANA)

Study characterizing the pharmacokinetic (PK) and safety of anesthetics and analgesics used in children and adolescents

Summary

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.

Publications

  • 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 ...

OVERVIEW

Status:
Enrolling

ClinicalTrials.gov Identifier:
NCT03427736

Principal Investigator:
Kanecia Zimmerman, MD, MPH
Duke Health, Durham, NC

NEWS

  • ANA Study Updates Protocol to Include New Medications
    The PTN’s Anesthesia and Analgesics in Children (ANA) study has updated its study protocol to include new medications to be studied in pediatric populations. These new medications being studied, known as drugs of interest (DOI), include morphine, oxycodone, and ketamine. Although often prescribed by providers for anesthetic and analgesic (or pain relief) reasons, the safety, ...
  • Anesthesia and Analgesics in Children (ANA) Hydromorphone Cohort Reaches Study Milestone
    The Pediatric Trials Network (PTN) Anesthesia and Analgesics in Children (ANA) study has recently closed enrollment for its hydromorphone drug of interest (DOI) cohort (or group of study participants), a major study milestone. This means the goal for participant enrollment for this DOI cohort has been reached for this pharmacokinetic (PK) study, and researchers can ...