What this study is
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.
What's being tested
- Preoperative Genotyping
Intervention · DIAGNOSTIC TEST
Genotype based risk prediction and personalized pain management
Study details
- Sponsor
- Senthil Sadhasivam
- Conditions
- PPAP · Spine Fusion
- Enrolling
- 300 people
- Starts
- 2022-09-20
- Est. completion
- 2027-10-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openUniversity of California
San Francisco, California, United States
- Ridhima Jain · ContactRidhma.jain@ucsf.edu
- Anshuman Sharma · Principal investigator
RecruitingChildren's Orthopaedic and Scoliosis Surgery Associates, LLP
St. Petersburg, Florida, United States
- Ryan E. Fitzgerald, MD · Contact813-506-5511rfitzgerald@chortho.com
- Priscilla Martinez · Contact813-506-5511pmartinez@chortho.com
- Ryan E. Fitzgerald, MD · Principal investigator
Not yet recruitingJohns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
- Frederick Kuo, MD · Contact410-929-2123frederick.kuo@jhmi.edu
- Janelle Maddox-Regis, MS, CIP · Contact443-927-1476Jmaddox3@jhmi.edu
- Frederick Kuo, MD · Principal investigator
Not yet recruitingRiley Children's Hospital
Indianapolis, Indiana, United States
- Senthil Packiasabhapathy, MD · Contactsepack@iu.edu
- Senthil Packiasabhapathy, MD · Principal investigator
RecruitingUPMC Children's Hospital
Pittsburgh, Pennsylvania, United States
- Senthilkumar Sadhasivam, MD, MPH · Contact412-647-2994sadhasivams@upmc.edu
Recruiting
Study team
Sponsor
Senthil Sadhasivam
Study ID STUDY21090075
Principal investigator
Senthilkumar Sadhasivam, MD, MPH
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.