Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB) (PPAP Spine)
S
Senthil Packiasabapathy
Primary Investigator
Enrolling By Invitation
10-17 years
All
Phase
N/A
300 participants needed
1 Location
Brief description of study
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 of study
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)
- 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.
- 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
You may be eligible for this study if you meet the following criteria:
- Conditions: PPAP, Spine Fusion
-
Age: Between 10 Years - 17 Years
-
Gender: All
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
Updated on
01 Aug 2024.
Study ID: STUDY21090075
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