Evaluation of Analgesia for Cardiac 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
Pediatric Cardiac Surgery
Interventions
DRUG

Methadone based ERAS

Children randomized to the methadone 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 4 hours after 1st dose) and postoperatively, up to 4 oral or IV 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

Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.

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