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Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
Sponsor: Senthil Sadhasivam
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.
Official title: Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Key Details
Gender
All
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-10-30
Completion Date
2029-08-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Methadone based ERAS
Methadone intervention includes intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.05 mg/kg up to a maximum of 2.5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral doses of methadone every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Non-methadone based group
Non-methadone intervention includes standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Postoperative pain medication is recommended when reported pain level is considered moderate or higher (≥4 on NRS and FLACC).
Locations (1)
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States