- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774499
Preoperative Oral Methadone for Patients Undergoing Cardiac Surgery: Reduction of Postoperative Pain
Study Overview
Detailed Description
Investigators propose a prospective, randomized, double-blind, placebo-controlled trial to investigate the effects of preoperative oral methadone on postoperative pain. The trial will be conducted in compliance with the protocol, Good Clinical Practice (GCP), and University of Saskatchewan Research Ethics Committee principles using an intent-to-treat model. The primary endpoint will be postoperative pain in the ICU, and secondary outcomes will include morphine requirements as measured by Patient Controlled Analgesia (PCA). Secondary endpoints include opioid consumption at 15 minutes and at 2, 4, 8, 12, 24, 48, and 72 hours post extubation. Other secondary endpoints include the following: pain with cough (using a 0-10 verbal pain scale) measured at the time of extubation then daily until post-op day three. Secondary outcomes that will be recorded from nursing assessment records include: incidence of nausea and/or vomiting requiring antiemetics, pruritus, hypoventilation (respiratory rate less than 8 breaths/min), hypoxemia (oxygen saturation less than 90%), time to extubation, and sedation (Richmond Agitation-Sedation Scale of -4 or -5).
Patients will receive a dose of either oral methadone or placebo prior to entering the operating room. The dose given will be 0.3 mg/kg (to a maximum of 30 mg) or equivalent volume of placebo. An blinded research assistant will receive an envelope the morning of surgery outlining if the patient is in group A or B as well as their weight in kg. For the methadone arm the research assistant will prepare the appropriate amount of methadone, which is dispensed as 10 mg/mL, and dilute it to a total volume of 5 mL in sugary syrup to mask its taste. For the placebo arm a similar volume will be mixed at a 0.3 mg/kg volume and diluted to a total volume of 5 mL of sugary syrup. The methadone or placebo will be given to the researcher in a syringe. The researcher will give syringe to the patient and the patient will administer the solution to themself orally prior to entering the operating room.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 5T6
- Saskatoon Health Region, 410 22nd Street East
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- presenting for elective first-time CABG cardiac surgery with anticipated extubation within 12 hours
Exclusion Criteria:
- < 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methadone
Methadone 0.3 mg/kg (to a maximum of 30 mg) will be given to the patient preoperatively.
|
0.3mg/kg of methadone given preoperatively (to maximum of 30mg)
|
Placebo Comparator: Placebo
Equivalent volume (5mL) of syrup will be given to the patient preoperatively.
|
equivalent volume (5mL) of syrup given preoperatively
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score (VRS)
Time Frame: 24 hours
|
Pain score as measured by 0-10 Verbal Rating Score (VRS)
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Morphine Consumption (mg)
Time Frame: 72 hours
|
Total dose in mg of IV morphine administered via Patient Controlled Analgesia
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72 hours
|
Pain score (VRS)
Time Frame: Up to 72 hours postoperative
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Pain score as measured by 0-10 Verbal Rating Score (VRS)
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Up to 72 hours postoperative
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Time to extubation
Time Frame: up to 24 hours postoperative
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Time from start of surgery until removal of endotracheal tube in ICU
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up to 24 hours postoperative
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Level of sedation
Time Frame: up to 72 hours postoperative
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Level of sedation as measured by the Richmond Agitation-Sedation Scale (RASS) in ICU
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up to 72 hours postoperative
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Incidence of opioid-related side effects
Time Frame: up to 72 hours postoperative
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Incidence of as nausea, vomiting, pruritus, hypoventilation, and hypoxia during a seventy-two hour monitoring period
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up to 72 hours postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William PS McKay, MD FRCPC, Department of Anesthesiology, University of Saskatchewan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Methadone
Other Study ID Numbers
- Bio16-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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