Methadone Versus Morphine for Orthopedic Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00892606
First received: April 30, 2009
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Fracture
Pain, Postoperative
Drug: Methadone
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Pre-Operative Methadone Versus Morphine for Post-Operative Analgesia in Orthopedic Surgery Patients

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Opioid consumption during the 48 hours after surgery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to initial dose of rescue analgesic [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Overall rescue analgesic [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Side effects with special attention paid to respiratory rate and possible respiratory depression, and PONV [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Overall satisfaction of the patient with the analgesic graded on a scale of 1-5 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone
Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
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
Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892606

Contacts
Contact: Anupama Wadhwa, MD 502-852-1005 anupama.wadhwa@louisville.edu

Locations
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Lynch, MBA    502-852-8266    susan.lynch@louisville.edu   
Principal Investigator: Anupama Wadhwa, MD         
Sub-Investigator: Jim Jackson, MD         
Sub-Investigator: David Seligson, MD         
Sub-Investigator: Heidi Koenig, MD         
Sub-Investigator: Laura Clark, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Anupama Wadhwa, MD University of Louisville
  More Information

Publications:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00892606     History of Changes
Other Study ID Numbers: UofL IRB # 08.0200
Study First Received: April 30, 2009
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Surgery, Orthopedic
Pain, Postoperative

Additional relevant MeSH terms:
Methadone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014