Personalized pain management for children undergoing spine surgery
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
This study is testing a new way to manage pain for children having spine surgery by using their genetic information to customize how much pain medication they get.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 5 sites (San Francisco, California and 4 other locations) |
| Trial ID | NCT05367609 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a personalized perioperative analgesia platform (PPAP) that links genetic factors to opioid metabolism in order to improve pain management for children undergoing posterior spinal fusion surgery. The approach involves preoperative genotyping to identify genetic variants that may predispose children to adverse effects from opioids, such as respiratory depression and opioid dependence. By tailoring opioid dosing based on these genetic insights, the study seeks to enhance pain relief and minimize complications associated with opioid use in the postoperative period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 10 to 21 who are undergoing posterior-lateral spinal fusion and require inpatient opioid treatment.
Not a fit: Patients with serious illnesses, severe preoperative pain, or a history of opioid misuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective pain management strategies for pediatric patients undergoing major surgeries.
How similar studies have performed: Other studies have shown promise in using genetic factors to personalize opioid therapy, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 4 other locations
- University of California — San Francisco, California, United States (Recruiting)
- Children's Orthopaedic and Scoliosis Surgery Associates, LLP — St. Petersburg, Florida, United States (Not_yet_recruiting)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Not_yet_recruiting)
- Riley Children's Hospital — Indianapolis, Indiana, United States (Recruiting)
- UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Senthilkumar Sadhasivam, MD, MPH — University of Pittsburgh
- Study coordinator: Senthilkumar Sadhasivam, MD, MPH
- Email: sadhasivams@upmc.edu
- Phone: 4126472994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.