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

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00665262
First received: April 18, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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
Arthroplasty
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of visual analogue scale scores greater than 4 [ Time Frame: post-op period ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00665262

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

No publications provided

Responsible Party: Dr Ngozi Imasogie, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00665262     History of Changes
Other Study ID Numbers: R-06-159, 12177
Study First Received: April 18, 2008
Last Updated: April 18, 2008
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014