Methadone-based pain control for children having elective heart surgery
Official title: Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
Run by University of Pittsburgh · NCT06626035 · Data updated 2026-11-12
This trial will try a standardized methadone-based recovery plan to see if it reduces pain, opioid use, and side effects for children aged 3 to under 18 after planned heart surgery compared with usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (Oakland, California and 2 other locations) |
| Status | Recruiting |
| Started | December 17, 2025 |
| Main results expected | January 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT06626035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 to <18 years, ASA physical status 1–3, whose guardians speak English or Spanish and who are scheduled for listed STS Category 1 or 2 elective cardiac surgeries are ideal candidates.
✕Probably not a fit
Children who are pregnant, allergic to methadone, have a prolonged preoperative QTc, or are taking contraindicated CYP450-inhibiting medications would be excluded and would not receive potential benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The multicenter PRECISE Analgesia trial will randomize about 1,000 children aged 3 to <18 undergoing planned STS Category 1 or 2 cardiac operations to either a multidose methadone-based enhanced recovery after surgery (ERAS) protocol or to standard short-acting opioid-based postoperative care. Patients will be assigned 1:1 and followed for acute pain, total opioid consumption, respiratory depression, nausea/vomiting, and the development of chronic postsurgical pain. Investigators will collect pharmacokinetic, genetic, clinical, and psychological data to develop precision dosing algorithms for methadone and oxycodone. Safety monitoring includes preoperative QTc screening and review for interacting medications.
Why it matters
Potential benefit: If successful, this approach could lower postoperative pain and overall opioid exposure while reducing opioid-related side effects in children after cardiac surgery.
How similar studies have gone: Adult studies and limited pediatric reports indicate perioperative methadone can reduce opioid needs and pain, but large randomized pediatric trials of multidose methadone ERAS remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States Recruiting -
UCSF Benioff Children's Hospital
Oakland, California, United States Not yet recruiting -
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Senthilkumar Sadhasivam, MD — University of Pittsburgh
- Study coordinator: Senthilkumar Sadhasivam, MD,MPH, MBA, FASA
- Email: sadhasivams@upmc.edu
- Phone: 4126474484
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.