Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

January 31, 2029

Study Completion Date

August 31, 2029

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: 0.05 mg/kg up to a maximum of 2.5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral doses of methadone 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).

Trial Locations (1)

15213

UPMC Children's Hospital, Pittsburgh

All Listed Sponsors
collaborator

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

NIH

lead

Senthil Sadhasivam

OTHER