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

This study has been completed.
Information provided by:
Lawson Health Research Institute Identifier:
First received: April 18, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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 Intervention Phase
Drug: tramacet
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

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

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

Enrollment: 10
Study Start Date: March 2006
Estimated Study Completion Date: December 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
comibined use of tramacet and naloxone infusion perioperatively
Drug: tramacet
2 tablets every 6 hours for 5 days


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
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Please refer to this study by its identifier: NCT00665262

Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
  More Information

Responsible Party: Dr Ngozi Imasogie, Lawson Health Research Institute Identifier: NCT00665262     History of Changes
Other Study ID Numbers: R-06-159
Study First Received: April 18, 2008
Last Updated: April 18, 2008

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 processed this record on May 25, 2017