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โ† Trials
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Perioperative Rectal Methadone in Spine Surgery

RecruitingPhase 4Ages 18 Years - 65 YearsAllUnity Health Toronto
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In plain words

What the trial is, and whether it could suit you

Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery. The main questions are: 1. Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial? 2. Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better t

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 18 to 65 years-old. 2. Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels 3. Capacity to provide informed consent 4. For participants of childbearing potential, use of contraception. Exclusion Criteria: 1. American Society of Anesthesiologists Physical Status \> IV 2. Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation 3. Pregnant or nursing participants 4. Known or suspected mechanical gastrointestinal obstruction 5. Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy 6. Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication 7. Severe central nervous system depression, increased intracranial pressure, or head injury 8. Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment 9. Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins 10. Preoperative renal insufficiency or failure 11. Significant liver disease (cirrhosis or hepatic failure) 12. History of opioid use disorder within the last 3 months 13. Patients taking more than 90 mg of morphine equivalents daily 14. Poor comprehension of the English language 15. Patients who are likely to remain intubated postoperatively 16. QT interval \> 500ms on preoperative ECG
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What it tests

  • Rectal Methadone administer during spinal surgery
  • Placebo: Rectal saline solution
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Where

1 site
St. Michael's Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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