Methadone-based pain control for children having elective heart surgery
Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
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 |
| Enrollment | 500 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06626035 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.