Evaluation of Analgesia for Cardiac Elective Surgery in Children
Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
Senthil Sadhasivam
500 participants
Dec 17, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria18
- 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 Criteria7
- 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
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Interventions
Children randomized to the methadone arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06626035