Methadone-Based Recovery for Pediatric Cardiac Surgery
(PRECISE Trial)
What You Need to Know Before You Apply
What is the purpose of 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 assigned to either research group.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids before the surgery, you may not be eligible to participate.
Is methadone safe for use in children undergoing surgery?
How is the drug methadone unique for pediatric cardiac surgery recovery?
Methadone is unique for pediatric cardiac surgery recovery because it has a longer duration of action and can reduce the need for other opioids and sedatives, potentially leading to shorter hospital stays and fewer side effects like constipation. It is used as a single-dose intravenous option to help with early extubation and better pain control compared to other opioids.13467
What data supports the effectiveness of the drug methadone for recovery after pediatric cardiac surgery?
Research suggests that methadone can help reduce the need for other pain medications and lower pain scores in children after surgery, which may lead to shorter hospital stays and fewer side effects like constipation. It has been shown to be effective in providing long-lasting pain relief compared to other opioids.13489
Who Is on the Research Team?
Senthilkumar Sadhasivam, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for children undergoing elective cardiac surgery. Specific eligibility details are not provided, but typically participants must meet certain health criteria and have parental consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Children undergo cardiac surgery and receive either methadone-based or standard-of-care analgesia protocols
Follow-up
Participants are monitored for safety, effectiveness, and adverse events post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
Methadone is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
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Who Is Running the Clinical Trial?
Senthil Sadhasivam
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator