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

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: 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Actual Primary Completion Date : November 30, 2010
Actual Study Completion Date : August 12, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxone

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   (Older Adult)
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 identifier (NCT number): NCT00665262

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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Ngozi Imasogie, MD Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute Identifier: NCT00665262    
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