Methadone Versus Morphine for Orthopedic Surgery Patients - Full Text View

Sponsor:	University of Louisville
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00892606

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 IV

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:

MedlinePlus related topics: Fractures

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2011 (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

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:

Wadhwa A, Clarke D, Goodchild CS, Young D. Large-dose oral dextromethorphan as an adjunct to patient-controlled analgesia with morphine after knee surgery. Anesth Analg. 2001 Feb;92(2):448-54.

Responsible Party:	Anupama Wadhwa, MD, 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:	August 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

Surgery, Orthopedic
Pain, Postoperative

Additional relevant MeSH terms:

Fractures, Bone
Pain, Postoperative
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Methadone
Morphine
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012