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The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral methadone, immediately prior to transport | Experimental |
| |
| Intravenous methadone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral methadone, immediately prior to transport | Drug | Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use in Morphine Milligram Equivalents 24 hours after extubation | From hospital admission for surgery to 24 hours after the patient is extubated postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use in Morphine Milligram Equivalents 48 hours after extubation | From hospital admission for surgery to 48 hours after the patient is extubated postoperatively | |
| Opioid Use in Morphine Milligram Equivalents 72 hours after extubation | From hospital admission for surgery to 72 hours after the patient is extubated postoperatively |
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Inclusion Criteria:
• Undergoing elective cardiac surgery as the first case of the day in an operating room
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krishnan Ramanujan | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 7, 2026 | 5 |
| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Intravenous methadone | Drug | Patients will receive 0.3mg/kg IV methadone after induction of general anesthesia |
|
| Pain score 6 hours after extubation | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. | From hospital admission for surgery to 6 hours after extubation postoperatively |
| Pain score 12 hours after extubation | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. | From hospital admission for surgery to 12 hours after extubation postoperatively |
| Pain score 24 hours after extubation | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. | From hospital admission for surgery to 24 hours after extubation postoperatively |
| Pain score 48 hours after extubation | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. | From hospital admission for surgery to 48 hours after extubation postoperatively |
| Pain score 72 hours after extubation | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. | From hospital admission for surgery to 72 hours after extubation postoperatively |
| Time to extubation | This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation). | From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. If the patient is extubated in the operating room, this time will be 0. |
| Opioid Use in MMEs Prior to Extubation | This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation). | From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. If the patient is extubated in the operating room, this time will be 0. |