Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:
• Age 10 - \< 18 years
• American Society of Anesthesiologists (ASA) Physical Status 1 or 2
• Undergoing PSF for idiopathic scoliosis
• Participant or legal guardian can speak and read English or Spanish
Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
UPMC Children's Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Senthilkumar Sadhasivam, MD, MPH, MBA, FASA
sadhasivams@upmc.edu
4126474484
Backup
Dayana Alsamsam, BSPS, MSc
alsamsamd@upmc.edu
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 500
Treatments
Experimental: Methadone-Based ERAS Group
The methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Active_comparator: Non-Methadone-Based Group
The comparator standard-of-care non-methadone-based analgesia arm will include standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.
Related Therapeutic Areas
Sponsors
Leads: Senthil Sadhasivam
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)