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Completed

NCT Number: NCT03495388

PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children

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.

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Key information

Conditions

Postoperative Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Dependence Opioid-Related Disorders Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Substance-Related Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Hospital for Children, Indianapolis, Indiana, United States

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About this study

Research procedures will include:

  • Pre-operative blood draw for genotyping candidate genes and exploratory genes and for future similar studies will be collected.
  • Standardized pre-, intra-, and post-operative care will be received by all participants. The study team will record medical history, demographic information, concomitant medications, vitals, pain scores, post-operative nausea and vomiting, and all medications given post-surgery for pain management throughout the participants in-patient stay.
  • Psychological questionnaires to assess pain, risk of developing OD and chronic pain, anxiety and depression will be administered pre-operatively, and 48-72 hours, 7-14 days, 2 months, 3 months, 6 months and 12 months post-operatively.
  • Quantitative Sensory Testing will be performed on up to 100 participants pre-operatively, and 48-72 hours,3 months and 12 months post-operatively.
  • Serial blood draws for oxycodone and methadone pharmacokinetic modeling will be collected from up to 200 participants. QTc measurements will also be recorded from pre- and post-operative EKGs for those participants in which methadone pharmacokinetic blood samples are collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Oxycodone

Drug

Post-op pain management medication

Primary outcomes

  1. Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects (RD and PONV).

    Time frame: Immediately post-surgery during hospital stay and at home up to 1 year post-surgery

    The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD, and PONV in the immediate post-surgical period (4 days) in the hospital and at home.

  2. Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone.

    Time frame: Immediately post-surgery during hospital stay and at home up to 1 year post-surgery

    The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital and at home.

Secondary outcomes

  1. Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic.

    Time frame: Pre-operative to post-operative day 2

    The investigators will look at CYP2D6 variants to find correlations in oxycodone's PK variability and the need for dose adjustments that lead to desired clinical outcomes in children undergoing major inpatient surgeries.

Other outcomes

  1. Look at genetic oxycodone-related perioperative and bio-psychological factors predisposing children to long-term adverse outcomes such as chronic persistant surgical pain and opioid dependence.

    Time frame: Pre-operative to 12 months post-operative

    The investigators will look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain and opioid dependence up to 1 year post-surgery. Children will also be asked to complete psychological questionnaires pre-surgery, and at 4 time points post-surgery to assess psycho-psychological factors that may correlate with chronic persistent surgical pain or opioid dependence.

Sponsors and collaborators

Lead sponsor

Senthil Sadhasivam

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Major Inpatient Surgery in Children

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2018
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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