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The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly

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ClinicalTrials.gov Identifier: NCT00665262
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
Ten patients 70 years and older having elective total hip/knee replacement surgery will be recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia. Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length of stay.

Condition or disease Intervention/treatment Phase
Arthroplasty Drug: tramacet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Prospective Feasibility Study
Actual Study Start Date : December 17, 2007
Primary Completion Date : November 30, 2010
Study Completion Date : August 12, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
comibined use of tramacet and naloxone infusion perioperatively
Drug: tramacet
2 tablets every 6 hours for 5 days

Primary Outcome Measures :
  1. opoid use post knee/hip arthroplasty [ Time Frame: post-op period ]

Secondary Outcome Measures :
  1. incidence of visual analogue scale scores greater than 4 [ Time Frame: post-op period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 70 years or older able to give consent able to communicate in English having elective hip/knee arthroplasty ASA physical status 1-3

Exclusion Criteria:

  • allergies to any of the following: naloxone, tramacet, NSAIDs, sulpha, or local anesthesic contraindication to spinal anesthesia contraindication to use of tramacet or celebrex ASA physical status4 chronic opiod use chronic pain syndrome

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 ClinicalTrials.gov identifier (NCT number): NCT00665262

Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Ngozi Imasogie, MD Lawson Health Research Institute

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00665262     History of Changes
Other Study ID Numbers: R-06-159
12177 ( Other Identifier: REB )
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Lawson Health Research Institute:
hip arthroplasty
knee arthroplasty

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents