Methadone for Recovery After Pediatric Heart Surgery
Evaluation of Analgesia for Cardiac Elective Surgery in Children
Recruiting
Phase 3
Interventional Study
Pediatric Cardiac Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Senthil Sadhasivam · Other
Who this trial is looking for
This trial is looking for children aged 3 to under 18 who are having certain heart surgeries. Participants will be randomly assigned to receive a special pain management plan with methadone or the usual recovery care.
Are You a Good Fit for This Trial?
You may be able to join if
- I am aged 3 to under 18 years old.
- I am having heart surgery that causes significant pain.
- I can read and speak English or Spanish.
You may not be able to join if
- I am pregnant.
- I am allergic to methadone.
- I have a heart condition with a long QT interval.
- I am taking certain medications that interact with methadone.
- I have used opioids in the 30 days before my surgery.
- I have severe sleep apnea.
- I have significant liver, kidney, or neurological disease.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 ass…
Trial Locations
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Eligibility 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:
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Contacts