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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Control (Intra-operative administration of opioids, other than methadone) |
|
| Treatment methadone 0.1 mg/kg | Active Comparator | methadone 0.1 mg/kg |
|
| Treatment methadone 0.15 mg/kg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methadone | Drug | Escalating dose of methadone up to .3mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Opioid Administration | Data on opioids administered intraoperatively will be collected from the subject's EMR. | 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] | EMR reviewed at 24 hours post-administration or at hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption Within First 30 Postoperative Days | Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit). | 30 days |
| Pain Relief Within First 30 Postoperative Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helga Komen, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29847382 | Derived | Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464. |
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We withdrew 4 patients after consenting - two of patients met exclusion criteria, one patient withdrew consent, one anesthesia provider refused to participate the study.
Recruitment was done between March 2015-May 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control (Intra-operative administration of opioids, other than methadone) |
| FG001 | Treatment Methadone 0.1 mg/kg | methadone methadone: Escalating dose of methadone up to .3mg/kg. |
| FG002 | Treatment Methadone 0.15 mg/kg | methadone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control (Intra-operative administration of opioids, other than methadone) Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone |
| BG001 | Treatment Methadone 0.1 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Opioid Administration | Data on opioids administered intraoperatively will be collected from the subject's EMR. | Posted | Median | Inter-Quartile Range | morphine equivalents mg | Administered at induction of anesthesia |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control (Intra-operative administration of opioids, other than methadone) Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helga Komen | Department of Anesthesiology Washington University in St. Louis | 3148527622 | komenh@anest.wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2017 | Feb 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Control (Intra-operative administration of opioids, other than methadone) | Drug | Intra-operative administration of opioids, other than methadone |
|
|
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.
| 30 days |
methadone 0.1 mg/kg methadone: Escalating dose of methadone up to .3mg/kg. |
| BG002 | Treatment Methadone 0.15 mg/kg | methadone: Escalating dose of methadone up to .3mg/kg. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body weight - kg | Mean | Standard Deviation | Kg |
|
| ASA status | ASA Physical Status Classification System ASA I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use ASA II A patient with mild systemic disease without substantive functional limitations. ASA III A patient with severe systemic disease with substantive functional limitations; | Number | units on a scale |
|
| Treatment Methadone 0.15 mg/kg |
methadone: Escalating dose of methadone up to .3mg/kg. |
|
|
|
| Primary | 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] | Posted | Median | Inter-Quartile Range | morphine equivalents mg | EMR reviewed at 24 hours post-administration or at hospital discharge |
|
|
|
|
| Secondary | Opioid Consumption Within First 30 Postoperative Days | Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit). | Posted | Median | Inter-Quartile Range | total postdischarge opioid pills used | 30 days |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 30 days |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Treatment Methadone 0.1 mg/kg | methadone 0.1 mg/kg methadone: Escalating dose of methadone up to .3mg/kg. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Treatment Methadone 0.15 mg/kg | methadone: Escalating dose of methadone up to .3mg/kg. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |