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Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

RecruitingPhase 3

Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)

Who can join

Ages 10 to 18 · All sexes

Full eligibility criteria

Inclusion Criteria:

1. Age 10 - \< 18 years
2. American Society of Anesthesiologists (ASA) Physical Status 1 or 2
3. Undergoing PSF for idiopathic scoliosis
4. Participant or legal guardian can speak and read English or Spanish

Exclusion Criteria:

1. Pregnant patients
2. Methadone allergy
3. Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
4. 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)
5. Preoperative opioid use within 30 days before surgery
6. History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
7. Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

About the study

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.

What is being tested

Methadone based ERAS (drug)
Non-methadone based group (drug)

Sponsor: Senthil Sadhasivam · Participants: 500 · Started: Oct 30, 2025

Contact the study team

Senthilkumar Sadhasivam, MD, MPH, MBA, FASA · Phone: 4126474484

Official record on ClinicalTrials.gov — NCT06626503

Locations in the U.S.

Ohio	Cincinnati Children's Hospital Medical Center, Cincinnati (Not yet recruiting)
Pennsylvania	UPMC Children's Hospital, Pittsburgh

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.