Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

Conditions

• Idiopathic Scoliosis

Eligibility Criteria

Sex

ALL

Age

10 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Methadone based ERAS — DRUG
  Methadone intervention includes 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 administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral 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.
• Non-methadone based group — DRUG
  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).

Study Details

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 Dates

Start date

Oct 30, 2025

Status verified

Feb 2026

Primary completion

Jan 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral 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.

Primary Outcome Measure

Average postoperative pain scores [ Time Frame: Postoperative 48 hours ]

Central Contacts

• Senthilkumar Sadhasivam, MD, MPH, MBA, FASA
  4126474484
  [email protected]
• Dayana Alsamsam, BSPS, MSc
  [email protected]

Locations (2)

Find similar trials in Cincinnati, OH

Related Studies

• Advanced SPinal Innovations With Robotics and Enabling Technology Registry
  Recruiting · Boston Children's Hospital · Los Angeles, California
• REFLECT Scoliosis System Post Approval Study
  Recruiting · Globus Medical Inc · Rochester, Minnesota
• A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.
  Recruiting · Thinks Works, PBC · Wilmington, Delaware
• A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
  Not Yet Recruiting · Globus Medical Inc · New York, New York