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New treatment option for Quality of Recovery Scores
Official title Methadone and Quality of Postoperative Recovery
ClinicalTrials.gov ID: NCT03168958
What this study is testing
What is Methadone?
Methadone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for quality of recovery scores.
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
- Patients undergoing cardiac surgery often experience moderate to severe pain in the early postoperative period. A number of methods have been used to help control pain after surgery; however, each of these techniques adds additional costs and risks.
- Phase 4: studies an already-approved treatment
- 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 18 to 90
You may be able to join if
- All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment
You likely can't join if
- Preoperative renal failure requiring dialysis or severe renal dysfunction (serum creatinine \> 2.0 mg/dL)
- Significant hepatic dysfunction (liver function tests \> 2 times upper normal limit)
- Pulmonary disease necessitating home oxygen therapy
- Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
- Allergy to methadone or fentanyl
- Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse
See the full eligibility criteria
- All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment
- Preoperative renal failure requiring dialysis or severe renal dysfunction (serum creatinine \> 2.0 mg/dL)
- Significant hepatic dysfunction (liver function tests \> 2 times upper normal limit)
- Pulmonary disease necessitating home oxygen therapy
- Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
- Allergy to methadone or fentanyl
- Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse
- Inability to speak or read the English language or neurologic conditions that may impair the ability to complete the QoR 40 questionnaire.
The study team makes the final eligibility decision.
Where it's taking place
- Evanston, Illinois, 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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Evanston, Illinois, 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.