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Evaluation of Analgesia for Cardiac Elective Surgery in Children
Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
Who can join
Ages 3 to 18 · All sexes
Full eligibility criteria
Inclusion Criteria: * Children aged 3-years - \<18 years * ASA physical status 1, 2, or 3 * Participant or legal guardian can speak and read English or Spanish * Undergoing the following cardiac surgeries (Categories 1 \& 2) that are associated with significant acute surgical pain STS Category 1: * ASD, PFO closure * VSD repairs, * Aortic stenosis sub-valvular repair * ASD and Partial anomalous venous return repair * AV canal transitional * Conduit replacement * Valve replacement (AVR, PVR) * TOF repair without ventriculostomy STS Category 2: * Glenn shunt (on Bypass only) * Fontan surgery (on Bypass only) * Pulmonary artery plasty (main) * Left Atrium (LA) to Pulmonary Artery (PA) conduit replacement. Exclusion Criteria: * Pregnant patients * Methadone allergy * Preoperative prolonged QTc more than 460 msec (-30 days to 0 day) * Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine) * Preoperative opioid use within 30 days before surgery * History of severe sleep apnea (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness) * Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator
About the study
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.
What is being tested
- Methadone based ERAS (drug)
- Non-methadone based group (drug)
Sponsor: Senthil Sadhasivam · Participants: 500 · Started: Dec 17, 2025
Contact the study team
- Senthilkumar Sadhasivam, MD,MPH, MBA, FASA · Phone: 4126474484
Official record on ClinicalTrials.gov — NCT06626035
Locations in the U.S.
| California | UCSF Benioff Children's Hospital, Oakland (Not yet recruiting) |
| Ohio | Cincinnati Children's Hospital Medical Center, Cincinnati (Not yet recruiting) |
| Pennsylvania | UPMC Children's Hospital, Pittsburgh |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.