Methadone-enhanced recovery for children having posterior spine fusion

Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)

This trial will test whether a multidose methadone-based enhanced recovery protocol reduces pain and opioid use in children (ages 10–17) undergoing posterior spine fusion for idiopathic scoliosis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 2 sites (Cincinnati, Ohio and 1 other locations)
• Trial ID: NCT06626503 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized Phase 3 trial compares a standardized multidose methadone-based enhanced recovery after surgery (ERAS) protocol to a non-methadone standard-of-care analgesic approach in children undergoing posterior spine fusion. Investigators will collect pharmacokinetic data, genetic information, and clinical and psychological measures to develop precision dosing models for methadone and oxycodone. The study aims to reduce acute pain, total opioid consumption, opioid-related adverse events (including respiratory depression and PONV), and the risk of chronic postsurgical pain. Sites include pediatric specialty centers where participants will be randomized and followed through the perioperative and early postoperative period.

Who should consider this trial

Good fit: Children aged 10 to under 18 with idiopathic scoliosis scheduled for posterior spine fusion, ASA physical status 1–2, and who can read/speak English or Spanish are ideal candidates.

Not a fit: Patients who are pregnant, allergic to methadone, have prolonged QTc, recent opioid use, severe sleep apnea, significant organ disease, or are taking strong CYP450 inhibitors are likely to be excluded or may not benefit.

Why it matters

Potential benefit: If successful, this approach could lower postoperative pain, reduce total opioid exposure and opioid-related side effects, and speed recovery for children after spine fusion.

How similar studies have performed: Single-dose intraoperative methadone has reduced postoperative opioid needs in adults and limited pediatric reports exist, but the multidose, precision-genetics ERAS approach in children is largely novel.

Eligibility criteria

Inclusion Criteria:

1. Age 10 - \< 18 years
2. American Society of Anesthesiologists (ASA) Physical Status 1 or 2
3. Undergoing PSF for idiopathic scoliosis
4. Participant or legal guardian can speak and read English or Spanish

Exclusion Criteria:

1. Pregnant patients
2. Methadone allergy
3. Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
4. Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
5. Preoperative opioid use within 30 days before surgery
6. History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
7. Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

Where this trial is running

Cincinnati, Ohio and 1 other locations

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (NOT_YET_RECRUITING)
• UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Senthilkumar Sadhasivam, MD — University of Pittsburgh
• Study coordinator: Senthilkumar Sadhasivam, MD, MPH, MBA, FASA

Conditions: Idiopathic Scoliosis