Pain Clinical Trial
Official title:
Preoperative Oral Methadone for Patients Undergoing Cardiac Surgery: Reduction of Postoperative Pain
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.
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.
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