Trial Outcomes & Findings for The Effect of Choice of Intraoperative Opioid on Postoperative Pain (NCT NCT01542645)

Results Overview

Total intravenous morphine used first three days (72 hours after ICU admission)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

164 participants

Primary outcome timeframe

First 3 days after surgery

Results posted on

2019-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Methadone Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Overall Study STARTED	82	82
Overall Study COMPLETED	77	79
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Choice of Intraoperative Opioid on Postoperative Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methadone n=77 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=79 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Total n=156 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 10.5 • n=93 Participants	65.5 years STANDARD_DEVIATION 11.1 • n=4 Participants	65.1 years STANDARD_DEVIATION 10.8 • n=27 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	16 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	52 Participants n=93 Participants	63 Participants n=4 Participants	115 Participants n=27 Participants

PRIMARY outcome

Timeframe: First 3 days after surgery

Total intravenous morphine used first three days (72 hours after ICU admission)

Outcome measures

Outcome measures
Measure	Methadone n=77 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=79 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Total Opioid Consumption in the Postoperative Period	8 milligrams Interval 0.0 to 44.0	14 milligrams Interval 2.0 to 146.0

SECONDARY outcome

Timeframe: 2 hours after cardiac surgery

Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable

Outcome measures

Outcome measures
Measure	Methadone n=77 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=79 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Postoperative Pain Scores	3 units on a scale Interval 0.0 to 8.0	4.5 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 1 months after surgery

Population: A home postal survey was sent to participants in the clinical trial 1 month after surgery. 46 patients in the methadone group and 58 patients in the fentanyl group returned the surveys

0=\< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Outcome measures
Measure	Methadone n=46 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=58 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Chronic Postoperative Pain Scores-Weekly Frequency of Pain	0 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 12 hours after surgery

In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect.

Outcome measures

Outcome measures
Measure	Methadone n=34 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=41 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Marker of Myocardial Injury (Troponin I)	5.4 nanograms per millimeter Interval 0.001 to 11.7	4.6 nanograms per millimeter Interval 0.7 to 30.0

SECONDARY outcome

Timeframe: 3 months

Population: A home postal survey was sent to participants in the clinical trial 3 months after surgery. 46 patients in the methadone group and 54 patients in the fentanyl group returned the surveys

0=\< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Outcome measures
Measure	Methadone n=46 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=54 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
3 Months-Chronic Pain-weekly Frequency of Pain	0 score on a scale Interval 0.0 to 2.0	0.5 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 6 months

Population: A home postal survey was sent to participants in the clinical trial 6 months after surgery. 42 patients in the methadone group and 39 patients in the fentanyl group returned the surveys

0=\< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Outcome measures
Measure	Methadone n=42 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=39 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
6 Months-Chronic Pain-weekly Frequency of Pain	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 12 months

Population: A home postal survey was sent to participants in the clinical trial 12 month after surgery. 31 patients in the methadone group and 34 patients in the fentanyl group returned the surveys

0=\< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

Outcome measures

Outcome measures
Measure	Methadone n=31 Participants Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.	Fentanyl n=34 Participants Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
12 Months-Chronic Pain-weekly Frequency of Pain	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Glenn Murphy, MD

NorthShore University HealthSystem

Phone: 847-570-2760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place