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New treatment option for Pediatric Cardiac Surgery
Official title Evaluation of Analgesia for Cardiac Elective Surgery in Children
ClinicalTrials.gov ID: NCT06626035
What this study is testing
What is Methadone based ERAS?
Methadone based ERAS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric cardiac surgery.
Also referred to as Methadone-Based.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- 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
You likely can't join if
- Pregnant patients
- Methadone allergy
- Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
- people undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin)...
- 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...
See the full eligibility 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.
- Pregnant patients
- Methadone allergy
- Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.