An interventional study of methadone and Control (Intra-operative administration of opioids, other than methadone) in Post-operative Pain and Anesthesia, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Control (Intra-operative administration of opioids, other than methadone)
Drug: Control (Intra-operative administration of opioids, other than methadone)
methadone 0.1 mg/kg
Drug: methadone
Drug: methadone
Escalating dose of methadone up to .3mg/kg.
Also known as: Dolophine
Intra-operative administration of opioids, other than methadone
Also known as: morphine fentanyl
Intraoperative Opioid Administration
Data on opioids administered intraoperatively will be collected from the subject's EMR.
Time frame: Administered at induction of anesthesia
Postoperative Opioid Administration
Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale \[0-no relief, 4-complete relief\]
Time frame: EMR reviewed at 24 hours post-administration or at hospital discharge
Opioid Consumption Within First 30 Postoperative Days
Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
Time frame: 30 days
Pain Relief Within First 30 Postoperative Days
Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient's 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.
Time frame: 30 days
Recruitment was done between March 2015-May 2016.
| Milestone | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg |
|---|---|---|---|
| Started | 21 | 18 | 21 |
| Completed | 21 | 18 | 21 |
| Not completed | 0 | 0 | 0 |
Data on opioids administered intraoperatively will be collected from the subject's EMR.
| morphine equivalents mg | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg |
|---|---|---|---|
| Intraoperative Opioid Administration | 25 (23.3 to 28.3) | 5.6 (5.0 to 6.0) | 8.6 (7.8 to 9.0) |
Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale \[0-no relief, 4-complete relief\]
| morphine equivalents mg | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg |
|---|---|---|---|
| Postoperative Opioid Administration | 10 (2.5 to 14.3) | 5.4 (3.3 to 9.6) | 3.3 (0.1 to 5.8) |
Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
| total postdischarge opioid pills used | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg |
|---|---|---|---|
| Opioid Consumption Within First 30 Postoperative Days | 10 (3 to 20) | 7 (4 to 19) | 5 (3 to 13) |
Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient's 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.
| score on a scale | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg |
|---|---|---|---|
| Pain Relief Within First 30 Postoperative Days | 1 (0 to 5) | 1 (0 to 6) | 0 (0 to 2) |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Treatment Methadone 0.1 mg/kg | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Treatment Methadone 0.15 mg/kg | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 18 | 21 | 60 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| Mean | 42 ± 13 | 37 ± 11 | 40 ± 11 | 40 ± 2.52 |
| Sex: Female, Male(Participants) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| Female | 18 | 16 | 21 | 55 |
| Male | 3 | 2 | 0 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 18 | 21 | 60 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 3 | 9 | 19 |
| White | 13 | 15 | 12 | 40 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| United States | 21 | 18 | 21 | 60 |
| body weight - kg(Kg) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| Mean | 85 ± 16 | 88 ± 42 | 86 ± 26 | 86 ± 1.53 |
| ASA status(units on a scale) | Control | Treatment Methadone 0.1 mg/kg | Treatment Methadone 0.15 mg/kg | Total |
|---|---|---|---|---|
| ASA I | 1 | 0 | 0 | 1 |
| ASA II | 16 | 17 | 21 | 54 |
| ASA III | 4 | 1 | 0 | 5 |
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Studies of the drug tested here: Methadone
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