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Methadone Versus Morphine for Orthopedic Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00892606
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : May 17, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
University of Louisville

Brief Summary:
The investigators propose to compare analgesia by methadone and ketamine with a combination of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The investigators hypothesize that when given with ketamine before surgical incision, methadone is more effective than morphine in reducing postoperative morphine consumption and reducing pain during movement.

Condition or disease Intervention/treatment Phase
Fracture Pain, Postoperative Drug: Methadone Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Pre-Operative Methadone Versus Morphine for Post-Operative Analgesia in Orthopedic Surgery Patients
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Methadone
Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine and 0.2 mg/kg of methadone IV with induction of general anesthesia.
Drug: Methadone
Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Other Names:
  • Symoron
  • Dolophine
  • Amidone
  • Methadose
  • Physeptone
  • Heptadon
  • 6-(Dimethylamino)-4,4-diphenylheptan-3-one (IUPAC name)

Active Comparator: Control
Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine (standard of care)
Drug: Morphine
Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Other Names:
  • Opiate
  • (5α,6α)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol

Primary Outcome Measures :
  1. Opioid Consumption During the 48 Hours After Surgery [ Time Frame: 48 hours ]
    The amount of opioid required for postoperative pain relief

Secondary Outcome Measures :
  1. Number of Participants With Post Operative Nausea and Vomiting [ Time Frame: 48 hours ]
    rates subjects experienced PONV

  2. Visual Pain Score [ Time Frame: 48 hours ]
    Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-65 years
  • Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
  • Surgery expected to last more than one hour
  • Patient expected to have moderate to severe post-operative pain
  • Patient refused regional anesthesia or has a contraindication to regional anesthesia

Exclusion Criteria:

  • Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
  • Difficulty or inability to understand the study or protocol
  • Known renal or hepatic dysfunction
  • BMI> 35
  • Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
  • Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
  • Pregnancy
  • Taking preoperative opioids for more than 2 weeks before the surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892606

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United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: Anupama Wadhwa, MD University of Louisville
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Responsible Party: University of Louisville Identifier: NCT00892606    
Other Study ID Numbers: UofL IRB # 08.0200
First Posted: May 4, 2009    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by University of Louisville:
Surgery, Orthopedic
Pain, Postoperative
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents