Summary

Eligibility
for people ages 10-21 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Anshuman Sharma

Description

Summary

The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.

Details

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia

Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)

  1. Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The investigators postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
  2. Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids

The investigators hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes

Keywords

PPAP, Spine Fusion, Pediatric, Spine Fusion Surgery, Preoperative Genotyping

Eligibility

You can join if…

Open to people ages 10-21

  • Children ages 10 to 21
  • ASA physical status 1 to 3
  • Undergoing Posterior-Lateral Spinal Fusion
  • Receives in-patient opioids
  • Prescribed opioids at discharge

You CAN'T join if...

  • Serious illness
  • Preoperative severe pain
  • Preoperative opioid use or misuse

Locations

  • University of California accepting new patients
    San Francisco California 38456 United States
  • Riley Children's Hospital accepting new patients
    Indianapolis Indiana 46202 United States
  • UPMC Children's Hospital accepting new patients
    Pittsburgh Pennsylvania 15224 United States

Lead Scientist at UCSF

  • Anshuman Sharma
    Professor, Anesthesia, School of Medicine. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Senthil Sadhasivam
ID
NCT05367609
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated