PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children
Completed
Conditions studied: Postoperative Pain, Opioid Dependence
In brief
Each year, in the U.S. alone, \>6 million children undergo painful surgery; up to 50% of them experience significant and serious side effects with opioids and inadequate pain relief. Though 60% of this inter-individual variability in responses results from genetic variations, there is an almost complete lack of understanding of how specific genetic variability affects pain and of the adverse effects of opioids, especially in children. In this project the investigators will focus on oxycodone, a standard and preferred post-surgical oral analgesic in children The purpose of this research is to study serious immediate and long-term clinical problems from both surgical pain and oxycodone use in children and adolescents to improve the safety and effectiveness of surgical pain relief. The long-term goals are to improve the safety and effectiveness of surgical pain relief with opioids (a class of drugs/pain relievers) and to minimize the societal burden of disabling Chronic Persistent Surgical Pain (CPSP, which is pain that persists even after the expected healing time from surgery) and Opioid Dependence (OD) by preoperative risk predictions and personalized care with the right dose of the right pain medication for each child. The overall objective is to determine the impact of risk factors on oxycodone's immediate and long-term negative postoperative outcomes and to personalize dosing in children undergoing outpatient and major inpatient surgery.
Key facts
- Study ID
- NCT03495388
- Run by
- Senthil Sadhasivam
- People needed
- 129
- Starts
- 2018-04-01
- Expected to finish
- 2022-06-15
- Last updated by the study team
- 2025-08-11
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Boy and girls
- All races
- ASA physical status 1 and 2
- Scheduled for pectus excavatum repair or idiopathic scoliosis spinal fusion
- Children with OSA will be included but stratified as they have more opioid-related complications.
You may not qualify if…
- Allergy to oxycodone or methadone
- Developmental delay
- Neurological disorder
- Renal or liver disease
- Pre-operative pain requiring analgesics
- On inhibitors or inducers of CYP2D6 and CYP3A
- Cannot read, write and speak English fluently
Where it is running
- Riley Hospital for Children — Indianapolis, Indiana, United States
- UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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