Clinical trial Recruiting at 3 sites Interventional Ages 10 to 21

Personalized pain management for children undergoing spine surgery

Official title: Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

Run by University of Pittsburgh · NCT05367609 · Data updated 2026-11-12

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

Study typeInterventional
Ages10 Years to 21 Years
SexAll
Enrollment300 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations5 sites (San Francisco, California and 4 other locations)
StatusRecruiting
StartedSeptember 20, 2022
Main results expectedApril 30, 2027
Study endsOctober 30, 2027
Registry record updatedSeptember 10, 2026
Trial IDNCT05367609 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with serious illnesses, severe preoperative pain, or a history of opioid misuse may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using genetic factors to personalize opioid therapy, suggesting that this approach may be effective.

Who can join: the full rules

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 it's running

  • University of California
    San Francisco, California, United States
    Recruiting
  • Riley Children's Hospital
    Indianapolis, Indiana, United States
    Recruiting
  • UPMC Children's Hospital
    Pittsburgh, Pennsylvania, 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

Study contacts

  • Principal investigator: Senthilkumar Sadhasivam, MD, MPH — University of Pittsburgh
  • Study coordinator: Senthilkumar Sadhasivam, MD, MPH
  • Email: sadhasivams@upmc.edu
  • Phone: 4126472994

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.