Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Status: Recruiting
Location: See location...
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 dosing1,2 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:
• Participants aged 10-\<18yrs for PSF trial
• ASA physical status 1\&2
• Undergoing PSF for idiopathic scoliosis
• Participant or legal guardian can speak and read English or Spanish
Locations
United States
Pennsylvania
UPMC Children's Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Amy Monroe, MPH, MBA
monroeal@upmc.edu
412-623-6283
Backup
Carly Riedmann, MPH
riedmannca@upmc.edu
412-623-4147
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 4 hours after 1st dose) and postoperatively, up to 4 oral or IV 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)