Trial Outcomes & Findings for Oral and Intravenous Methadone for Analgesia in Cardiac Surgery (NCT NCT06720415)
NCT ID: NCT06720415
Last Updated: 2026-08-06
Results Overview
Oral morphine milligram equivalents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Results posted on
2026-08-06
Participant Flow
Patients were enrolled between April and July 2025, with the first patient being accrued on April 14 and the last being accrued on July 7. Potential study subjects were approached in preoperative clinic or contacted via telephone to discuss the study including risks, benefits, and alternatives.
There were no patients who were excluded from this study between enrollment and randomization.
Participant milestones
| Measure |
Oral Methadone, Immediately Prior to Transport
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
Intravenous Methadone
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Oral Methadone, Immediately Prior to Transport
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
Intravenous Methadone
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Oral Methadone, Immediately Prior to Transport
n=21 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
Intravenous Methadone
n=20 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 16 • n=20 Participants
|
62.7 Years
STANDARD_DEVIATION 11.7 • n=20 Participants
|
62.2 Years
STANDARD_DEVIATION 13.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Weight (kg)
|
85.8 kg
STANDARD_DEVIATION 22.5 • n=20 Participants
|
94.0 kg
STANDARD_DEVIATION 20.1 • n=20 Participants
|
89.9 kg
STANDARD_DEVIATION 21.5 • n=40 Participants
|
|
Height (cm)
|
174.8 cm
STANDARD_DEVIATION 12.1 • n=20 Participants
|
173.0 cm
STANDARD_DEVIATION 10.5 • n=20 Participants
|
173.9 cm
STANDARD_DEVIATION 11.2 • n=40 Participants
|
|
BMI
|
27.8 kg/m^2
n=20 Participants
|
29.6 kg/m^2
n=20 Participants
|
28.3 kg/m^2
n=40 Participants
|
|
American Society of Anesthesiologists Physical Status Classification
|
4 Scores on a scale
n=20 Participants
|
4 Scores on a scale
n=20 Participants
|
4 Scores on a scale
n=40 Participants
|
|
Beta blocker use
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Calcium channel blocker use
|
5 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
ACE inhibitor use
|
0 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
ARB use
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Diuretic use
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Nitrate use
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Asthma
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Obstructive sleep apnea
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
COPD
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Chronic kidney disease
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From hospital admission for surgery to 24 hours after the patient is extubated postoperativelyOral morphine milligram equivalents
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Opioid Use in Morphine Milligram Equivalents 24 Hours After Extubation
|
48.0 Oral morphine milligram equivalents
Interval 19.0 to 68.0
|
38 Oral morphine milligram equivalents
Interval 7.5 to 57.0
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 48 hours after the patient is extubated postoperativelyOral morphine milligram equivalents
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Opioid Use in Morphine Milligram Equivalents 48 Hours After Extubation
|
72 Oral morphine milligram equivalents
Interval 52.5 to 99.25
|
57 Oral morphine milligram equivalents
Interval 13.25 to 89.375
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 72 hours after the patient is extubated postoperativelyOral morphine milligram equivalents
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Opioid Use in Morphine Milligram Equivalents 72 Hours After Extubation
|
98 Oral morphine milligram equivalents
Interval 57.25 to 129.75
|
60.5 Oral morphine milligram equivalents
Interval 13.25 to 103.375
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 6 hours after extubation postoperativelyPain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Pain Score 6 Hours After Extubation
|
4 Scores on a scale
Interval 0.0 to 5.0
|
3 Scores on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 12 hours after extubation postoperativelyPain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Pain Score 12 Hours After Extubation
|
4 Scores on a scale
Interval 2.0 to 5.0
|
3 Scores on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 24 hours after extubation postoperativelyPain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Pain Score 24 Hours After Extubation
|
3 Scores on a scale
Interval 2.0 to 5.0
|
3 Scores on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 48 hours after extubation postoperativelyPain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Pain Score 48 Hours After Extubation
|
3 Scores on a scale
Interval 1.0 to 4.0
|
2 Scores on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: From hospital admission for surgery to 72 hours after extubation postoperativelyPain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Pain Score 72 Hours After Extubation
|
2 Scores on a scale
Interval 0.0 to 3.0
|
0 Scores on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.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).
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Time to Extubation
|
204.5 Minutes
Interval 136.8 to 366.8
|
225 Minutes
Interval 130.0 to 360.0
|
SECONDARY outcome
Timeframe: From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation).
Outcome measures
| Measure |
Intravenous Methadone
n=19 Participants
Subjects received 0.3mg/kg actual body weight of intravenous methadone in the operating room. The timing of intraoperative administration was left to the discretion of the anesthesia team. The remainder of perioperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative care teams.
|
Oral Methadone, Immediately Prior to Transport
n=19 Participants
Subjects received 0.4mg/kg (actual body weight) of oral methadone immediately prior to being transported to the operating room by the anesthesia team. The remainder of the intraoperative and postoperative care was not affected by the study and at the discretion of the surgical, anesthesia, and postoperative teams.
|
|---|---|---|
|
Opioid Use in MMEs Prior to Extubation
|
25 Oral morphine milligram equivalents
Interval 10.0 to 25.0
|
25 Oral morphine milligram equivalents
Interval 25.0 to 30.0
|
Adverse Events
Oral Methadone, Immediately Prior to Transport
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Intravenous Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place