A Phase 2 interventional study of Methadone and Placebo in Pain, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by University of Saskatchewan · Phase 2, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 21 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methadone 0.3 mg/kg (to a maximum of 30 mg) will be given to the patient preoperatively.
Drug: Methadone
Equivalent volume (5mL) of syrup will be given to the patient preoperatively.
Drug: Placebo
0.3mg/kg of methadone given preoperatively (to maximum of 30mg)
equivalent volume (5mL) of syrup given preoperatively
Pain score (VRS)
Pain score as measured by 0-10 Verbal Rating Score (VRS)
Time frame: 24 hours
Total Morphine Consumption (mg)
Total dose in mg of IV morphine administered via Patient Controlled Analgesia
Time frame: 72 hours
Pain score (VRS)
Pain score as measured by 0-10 Verbal Rating Score (VRS)
Time frame: Up to 72 hours postoperative
Time to extubation
Time from start of surgery until removal of endotracheal tube in ICU
Time frame: up to 24 hours postoperative
Level of sedation
Level of sedation as measured by the Richmond Agitation-Sedation Scale (RASS) in ICU
Time frame: up to 72 hours postoperative
Incidence of opioid-related side effects
Incidence of as nausea, vomiting, pruritus, hypoventilation, and hypoxia during a seventy-two hour monitoring period
Time frame: up to 72 hours postoperative
Plan to share: Yes
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Saskatchewan