NCT02774499

Brief Summary

Oral medications like gabapentin and acetaminophen are commonly given to patients prior to surgery to provide balanced anaesthesia. Intravenous methadone has been shown to decrease postoperative pain as well as postoperative nausea and vomiting, which are known barriers to discharge. Oral methadone would be a convenient alternative to give as a preoperative medication with its bioavailability approaching 80%. No clinical trials to date have explored the utility of oral methadone as a preoperative analgesic to improve postoperative outcomes. Current literature shows preoperative IV methadone reduces opioid consumption in the perioperative period for cardiac surgeries; therefore, investigators hypothesize that preoperative oral methadone will also reduce postoperative pain and opioid consumption in patients undergoing sternotomy for cardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Apr 2016

Typical duration for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

April 6, 2016

Last Update Submit

December 28, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score (VRS)

    Pain score as measured by 0-10 Verbal Rating Score (VRS)

    24 hours

Secondary Outcomes (5)

  • Total Morphine Consumption (mg)

    72 hours

  • Pain score (VRS)

    Up to 72 hours postoperative

  • Time to extubation

    up to 24 hours postoperative

  • Level of sedation

    up to 72 hours postoperative

  • Incidence of opioid-related side effects

    up to 72 hours postoperative

Study Arms (2)

Methadone

EXPERIMENTAL

Methadone 0.3 mg/kg (to a maximum of 30 mg) will be given to the patient preoperatively.

Drug: Methadone

Placebo

PLACEBO COMPARATOR

Equivalent volume (5mL) of syrup will be given to the patient preoperatively.

Drug: Placebo

Interventions

MethadoneDRUG

0.3mg/kg of methadone given preoperatively (to maximum of 30mg)

Methadone
PlaceboDRUG

equivalent volume (5mL) of syrup given preoperatively

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presenting for elective first-time CABG cardiac surgery with anticipated extubation within 12 hours

You may not qualify if:

  • \< 18 years of age
  • preoperative renal failure requiring dialysis or serum creatinine greater than 176 µmol/L
  • significant hepatic dysfunction (liver function tests more than twice the upper limit of normal)
  • ejection fraction less than 30%
  • corrected QT interval (QTc) on ECG \> 440ms for men and 450ms for women
  • pulmonary disease necessitating home oxygen therapy
  • preoperative requirement for inotropic agents or intra-aortic balloon pump to maintain hemodynamic stability
  • emergency surgery
  • allergy to methadone
  • use of preoperative opioids or recent history of opioid abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saskatoon Health Region, 410 22nd Street East

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

Related Publications (1)

  • Bolton TM, Chomicki SO, McKay WP, Pikaluk DR, Betcher JG, Tsang JC. Preoperative oral methadone for postoperative pain in patients undergoing cardiac surgery: A randomized double-blind placebo-controlled pilot. Can J Pain. 2019 Apr 9;3(1):49-57. doi: 10.1080/24740527.2019.1575695. eCollection 2019.

    PMID: 35005393DERIVED

MeSH Terms

Conditions

Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • William PS McKay, MD FRCPC

    Department of Anesthesiology, University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD FRCPC

Study Record Dates

First Submitted

April 6, 2016

First Posted

May 17, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

Locations

CA(1)