Studying Methadone-Based Pain Relief Compared to Standard Care After Spine Fusion Surgery in Children Ages 10 to Under 18

What this Trial Is About

Researchers are studying pain management for children aged 10 to under 18 years undergoing elective surgery for idiopathic scoliosis, specifically posterior spine fusion PSF. This study aims to evaluate the safety and effectiveness of a multidose methadone-based enhanced recovery after surgery ERAS protocol compared to standard short-acting opioid pain treatments. The goal is to improve surgical pain control while reducing opioid-related side effects and long-term opioid use in children. The study involves two treatment groups one group will receive a standardized multidose methadone-based analgesia including intraoperative intravenous doses before and after surgery, followed by additional doses every 12 hours until hospital discharge. The other group will receive the current standard opioid pain management without methadone. Researchers will also use genetic and clinical data to develop personalized dosing strategies for methadone and oxycodone to optimize pain relief and minimize risks. Participants will be monitored closely during the postoperative period with assessments of pain levels, opioid use, respiratory function, nausea, sedation, heart rhythm, and length of hospital stay. Follow-up will include evaluation of persistent opioid use, chronic postsurgical pain, and opioid dependence up to three months after surgery. The study will enroll approximately 1000 children across multiple centers, with detailed genetic and clinical data collection to personalize future pain management.

Evaluation of Analgesia for Spine Fusion Elective Surgery in Children