Evaluation of Analgesia for Cardiac Elective Surgery in Children

Recruiting now · Phase 3

Conditions studied: Pediatric Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT06626035

Run by

Senthil Sadhasivam

People needed

500

Starts

2025-12-17

Expected to finish

2029-08-31

Last updated by the study team

2026-08-07

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• UCSF Benioff Children's Hospital — Oakland, California, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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