Methadone-enhanced recovery for children having posterior spine fusion

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• UPMC Children's Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• Riley Children's Hospital
  Indianapolis, Indiana, United States Not yet recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Not yet recruiting
• Texas Children's Hospital
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Senthilkumar Sadhasivam, MD — University of Pittsburgh
• Study coordinator: Senthilkumar Sadhasivam, MD, MPH, MBA, FASA
• Email: sadhasivams@upmc.edu
• Phone: 4126474484

Similar studies

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

• Resilient Scoliosis Brace in kids with idiopathic scoliosis

  A brace worn daily by kids with idiopathic scoliosis to see if it can stop the curve from getting worse during growth and to check comfort and usability.

  Recruiting Thinks Works, PBC · Wilmington, Delaware · NCT07574632

• Morning bright light therapy to slow or prevent adolescent idiopathic scoliosis

  This will try morning bright light therapy to see if it can slow curve progression or prevent new scoliosis in 10–15-year-olds who have evening sleep patterns.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Zhejiang, Zhejiang · NCT07424703

• Characterization of Visual Perception Impairments in Idiopathic Scoliosis

  This study tests whether teens with idiopathic scoliosis have visual perception issues that relate to balance, compared with their peers.

  Recruiting Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Lyon · NCT07356999

• Vitamin A supplementation for children with idiopathic scoliosis

  This test gives daily vitamin A to children with idiopathic scoliosis who have low vitamin A to see if it reduces curve size or prevents new curves.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT07335991

• Adenotonsillectomy and spinal curve changes in children with sleep-disordered breathing

  This trial will test whether removing the adenoids and tonsils can reduce or prevent worsening of spinal curves in children aged 6–15 who have mild sleep-disordered breathing and scoliosis or are at risk.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT07332780

• Enhanced Recovery After Surgery for Adolescent Idiopathic Scoliosis Surgery

  This study tests whether an enhanced recovery after surgery (ERAS) protocol helps teens recover after spinal fusion for idiopathic scoliosis.

  Recruiting at 11 sites Hospices Civils de Lyon · Amiens and 10 other locations · NCT06908213

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.