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 study hydromorphone, an analgesic drug, in children.

The study’s principal investigator, Dr. Kanecia Zimmerman, and researchers are seeking to determine the appropriate dosing for anesthesia and analgesia drugs, which are administered to children for inpatient and outpatient surgical procedures to treat pain and anxiety. Many commonly used analgesia and anesthesia drugs are not prescribed to children due to their lack of safety and efficacy dosing guidelines in pediatric populations. The goal of this study is to determine how children’s bodies break down these drugs, and establish pediatric dosing guidelines for prescribers.

This study will enroll participants aged 2 to 17 who are already receiving an anesthetic or analgesic drug as part of their routine care. The recruited participants will not be randomized for this study due to their needed drug therapy. The following DOI cohorts were established for this study, with approximately 60 participants assigned to each cohort:  hydromorphone (analgesic), ketorolac (analgesic), ketamine (anesthetic), oxycodone (analgesic), and morphine (analgesic).  The drugs being studied are administered to children during their regular care. Once the study is completed, the results will be submitted to the U.S. Food and Drug Administration (FDA) to change the information and dosing guidelines for pediatric dosing.