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Evaluation of Analgesia for Cardiac Elective Surgery in Children

RECRUITING

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.

I'm interested

ALL
3 years to 18 years old
This study is NOT accepting healthy volunteers

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

DRUG: Methadone based ERAS, DRUG: Non-methadone based group

Pediatric Cardiac Surgery

Isabelle Allen - isabelle.allen@cchmc.org
PHASE3
NCT06626035
See this study on ClinicalTrials.gov

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