Actively Recruiting
Evaluation of Analgesia for Cardiac Elective Surgery in Children
Led by Senthil Sadhasivam · Updated on 2026-05-05
500
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
S
Senthil Sadhasivam
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Analgesia for Cardiac Elective Surgery in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to less than 18 years
- ASA physical status 1, 2, or 3
- Participant or legal guardian can speak and read English or Spanish
- Undergoing specified cardiac surgeries including ASD, PFO closure, VSD repairs, aortic stenosis sub-valvular repair, AV canal transitional, conduit replacement, valve replacement, TOF repair without ventriculostomy, Glenn shunt, Fontan surgery, pulmonary artery plasty, or LA to PA conduit replacement
You will not qualify if you...
- Pregnant patients
- Allergy to methadone
- Preoperative prolonged QTc interval over 460 msec within 30 days before surgery
- Use of cytochrome P450 inhibitors known to interact with methadone
- Opioid use within 30 days before surgery
- History of severe sleep apnea (AHI >10 or clinical signs)
- Significant liver, kidney, neurological disease, developmental delay, or other major medical conditions as determined by the study investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Senthilkumar Sadhasivam, MD,MPH, MBA, FASA
CONTACT
D
Dayana Alsamsam, BSPS, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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