NCT06626035 Evaluation of Analgesia for Cardiac Elective Surgery in Children
| NCT ID | NCT06626035 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Senthil Sadhasivam |
| Condition | Pediatric Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2025-12-17 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Senthilkumar Sadhasivam, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06626035 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Pediatric Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06626035 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT06626035 currently recruiting?
Yes, NCT06626035 is actively recruiting participants. Contact the research team at sadhasivams@upmc.edu for enrollment information.
Where is the NCT06626035 trial being conducted?
This trial is being conducted at Oakland, United States, Cincinnati, United States, Pittsburgh, United States.
Who is sponsoring the NCT06626035 clinical trial?
NCT06626035 is sponsored by Senthil Sadhasivam. The principal investigator is Senthilkumar Sadhasivam, MD at University of Pittsburgh. The trial plans to enroll 500 participants.