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Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

NCT06626503 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

Interventions

DRUG

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: 0.1 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.

DRUG

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).

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Senthil Sadhasivam

    lead OTHER

Principal Investigators

  • Senthilkumar Sadhasivam, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2029-01-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626503 on ClinicalTrials.gov