Personalized Pain Management for Pediatric Spine Fusion Surgery
This study is developing a personalized approach to pain management for children and young adults (ages 10-21) undergoing spine fusion surgery. It uses a "Personalized Perioperative Analgesia Platform" (PPAP) which involves genetic testing (genotyping) before surgery. The goal is to understand how your genes might affect your response to pain medications like oxycodone and methadone, and your risk of side effects such as breathing problems (respiratory depression) or nausea and vomiting after surgery. Researchers also want to see if this personalized approach can help reduce long-term issues like opioid dependence or ongoing pain. The study aims to enroll 300 participants who are generally healthy, receiving inpatient opioids, and prescribed opioids at discharge.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention (preoperative genotyping). It aims to enroll 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed immediately after surgery for up to 4 days, and then at home for up to 1 year post-surgery.
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Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Senthilkumar Sadhasivam, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)Immediately post-surgery up to 4 days in patient
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital
- Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodoneAt home up to 1 year post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the post-surgical period at home up to 1-year
- Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodoneImmediately post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.
- Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodoneAt home up to 1 year post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.