Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

Recruiting now · Phase 3

Conditions studied: Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT06626503

Run by

Senthil Sadhasivam

People needed

500

Starts

2025-10-30

Expected to finish

2029-08-31

Last updated by the study team

2026-05-05

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant patients
• Methadone allergy
• Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
• Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
• Preoperative opioid use within 30 days before surgery
• History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
• Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

Where it is running

• UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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