Pain, PostoperativePhase 4OMICSNCT07221617
Oral Methadone in Cardiac Surgery
A Phase 4 study testing Methadone, oral and Methadone, intravenously in people with Pain, Postoperative and Anesthesia, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Cardiac Surgery
- What is being tested?
- Methadone, oral and Methadone, intravenously
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 25 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective cardiac surgery
Who cannot join
- Chronic pain requiring opioid medications as an outpatient
- Opioid use disorder on medication assistance treatment
- Prolonged QTc >500ms
- Chronic kidney disease with eGFR < 30mL/min
- Documented cirrhosis
- Intolerance to methadone
Show all 9Show fewer
- Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery
- Pregnancy at the time of surgery
- Subsequent surgeries after index surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Oral Methadone In Cardiac Surgery
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.
- Conditions
- Pain, Postoperative, Anesthesia, Cardiac Surgery
- Being tested
- Methadone, oral, Methadone, intravenously
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone, oralDrug
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
Methadone, intravenouslyDrug
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intravenous methadone intraoperatively | Active comparator | Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery Receives: Drug: Methadone, intravenously |
| Oral methadone, immediately prior to transport | Experimental | Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery Receives: Drug: Methadone, oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of opioid medication used 72 hours post-extubation
Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents
Measured: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
Secondary outcomes (6)
Amount of opioid medication used 24 hours post-extubation
Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents
Measured: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Amount of opioid medication used 48 hours post-extubation
Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents
Measured: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
Amount of opioid medication required throughout hospitalization
Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents
Measured: From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
Amount of opioid medication required prior to extubation
Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents.
Measured: From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
Pain scores after extubation
Pain will be assessed by nursing staff using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
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).
Measured: From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start13 Jan 2026
- Primary completion22 Aug 2026
- Study completion25 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishnan Ramanujan, Mayo Clinic
- Investigators
- Krishnan Ramanujan, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221617
- Sponsor's protocol ID
- 25-007292
- Acronym
- OMICS
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Methadone In Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07221617
- Acronym / sponsor ID
- OMICS / 25-007292
- Conditions
- Pain, Postoperative, Anesthesia, Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 22 Aug 2026 (actual)
- Study completion
- 25 Oct 2026 (actual)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous methadone intraoperatively | Active comparator | Drug: Methadone, intravenouslySubjects in the IV methadone arm will receive methadone intravenously during cardiac surgery |
| Oral methadone, immediately prior to transport | Experimental | Drug: Methadone, oralSubjects in the oral methadone arm will receive methadone orally prior to cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective cardiac surgery
Key exclusion criteria (9 listed)
- Chronic pain requiring opioid medications as an outpatient
- Opioid use disorder on medication assistance treatment
- Prolonged QTc >500ms
- Chronic kidney disease with eGFR < 30mL/min
- Documented cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone, oralPatients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room | Drug | Oral methadone, immediately prior to transport |
| Methadone, intravenouslyPatients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia | Drug | Intravenous methadone intraoperatively |
Primary outcome
Amount of opioid medication used 72 hours post-extubation
Time frame: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents
6 secondary outcomes
Amount of opioid medication used 24 hours post-extubation
Time frame: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Amount of opioid medication used 48 hours post-extubation
Time frame: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
Amount of opioid medication required throughout hospitalization
Time frame: From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
Amount of opioid medication required prior to extubation
Time frame: From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
Pain scores after extubation
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
Time to extubation
Time frame: From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishnan Ramanujan, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone, oral and Methadone, intravenously in people with Pain, Postoperative and Anesthesia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of opioid medication used 72 hours post-extubation (time frame: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.