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Evaluation of Analgesia for Cardiac Elective Surgery in Children
Sponsor: Senthil Sadhasivam
Summary
The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.
Official title: Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-12-17
Completion Date
2029-08-31
Last Updated
2026-08-07
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (3)
UCSF Benioff Children's Hospital
Oakland, California, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States