drugset / Trial / NCT06626503
Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
Phase 3
Recruiting
500 enrolled
Senthil Sadhasivam
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2025-10-30
- Primary completion
- 2029-01-31
- Completion
- 2029-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methadone | Other / unclassified | 0.1 mg/kg | Intravenous |