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Methadone in Ambulatory Surgery

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ClinicalTrials.gov Identifier: NCT02300077
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Anesthesia Drug: methadone Drug: Control (Intra-operative administration of opioids, other than methadone) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Methadone in Ambulatory Surgery
Actual Study Start Date : December 2014
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Control (Intra-operative administration of opioids, other than methadone)
Drug: Control (Intra-operative administration of opioids, other than methadone)
Intra-operative administration of opioids, other than methadone
Other Name: morphine fentanyl

Active Comparator: Treatment methadone 0.1 mg/kg
methadone 0.1 mg/kg
Drug: methadone
Escalating dose of methadone up to .3mg/kg.
Other Name: Dolophine

Active Comparator: Treatment methadone 0.15 mg/kg Drug: methadone
Escalating dose of methadone up to .3mg/kg.
Other Name: Dolophine




Primary Outcome Measures :
  1. Intraoperative Opioid Administration [ Time Frame: Administered at induction of anesthesia ]
    Data on opioids administered intraoperatively will be collected from the subject's EMR.

  2. Postoperative Opioid Administration [ Time Frame: EMR reviewed at 24 hours post-administration or at hospital discharge ]
    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]


Secondary Outcome Measures :
  1. Opioid Consumption Within First 30 Postoperative Days [ Time Frame: 30 days ]
    Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).

  2. Pain Relief Within First 30 Postoperative Days [ Time Frame: 30 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
  • Signed, written, informed consent

Exclusion Criteria:

  • History of or known liver or kidney disease.
  • Females who are pregnant or nursing.
  • Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
  • History of allergy to methadone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300077


Locations
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United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Helga Komen, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02300077     History of Changes
Other Study ID Numbers: 201408002
First Posted: November 24, 2014    Key Record Dates
Results First Posted: May 17, 2019
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
fentanyl, morphine
methadone

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Morphine
Fentanyl
Methadone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antitussive Agents
Respiratory System Agents