Methadone in Ambulatory Surgery

NCT02300077 | Completed Results

• 1 other identifier: 201408002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain; Anesthesia

Keywords

fentanyl, morphine; methadone

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Opioid Consumption Within First 30 Postoperative Days

  30 days

• Pain Relief Within First 30 Postoperative Days

  30 days

Study Arms (3)

Control

ACTIVE COMPARATOR

Control (Intra-operative administration of opioids, other than methadone)

Drug: Control (Intra-operative administration of opioids, other than methadone)

Treatment methadone 0.1 mg/kg

ACTIVE COMPARATOR

methadone 0.1 mg/kg

Drug: methadone

Treatment methadone 0.15 mg/kg

ACTIVE COMPARATOR

Drug: methadone

Interventions

methadone DRUG

Escalating dose of methadone up to .3mg/kg.

Also known as: Dolophine

Treatment methadone 0.1 mg/kg; Treatment methadone 0.15 mg/kg

Control (Intra-operative administration of opioids, other than methadone) DRUG

Intra-operative administration of opioids, other than methadone

Also known as: morphine fentanyl

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 29847382 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Results Point of Contact

• Title: Helga Komen
• Organization: Department of Anesthesiology Washington University in St. Louis

komenh@anest.wustl.edu

3148527622

Study Officials

• Helga Komen, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: May 17, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)