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Clinical Trial 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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05367609
Study type Interventional
Source University of Pittsburgh
Contact Senthilkumar Sadhasivam, MD, MPH
Phone 4126472994
Email sadhasivams@upmc.edu
Status Recruiting
Phase N/A
Start date September 20, 2022
Completion date September 2025

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