Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (Sirb)

SP

Senthil Packiasabapathy

Principal Investigator

Status: Enrolling By Invitation Ages: 10 Years - 17 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

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

Detailed Description

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, andzing analgesia
Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posteriorusion (PSF)
  1. Determine genetic factors predisposing children to immediate and long-term postoperativehadone and oxycodone related adverse effects including RD, PONV, opioid dependence,d 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 ofds
The investigators hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precisiond use for optimal clinical outcomes

Eligibility of study

Inclusion Criteria:
  • Children ages 10 to 21
  • ASA physical status 1 to 3
  • Undergoing Posterior-Lateral Spinal Fusion
  • Receives in-patient opioids
  • Prescribed opioids at discharge
Exclusion Criteria:
  • Serious illness
  • Preoperative severe pain
  • Preoperative opioid use or misuse

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.