The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly
Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00665262
Collaborator
(none)
10
1
1
43.8
0.2
Study Details
Study Description
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 |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
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
:
Dec 17, 2007
Actual Primary Completion Date
:
Nov 30, 2010
Actual Study Completion Date
:
Aug 12, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 comibined use of tramacet and naloxone infusion perioperatively |
Drug: tramacet
2 tablets every 6 hours for 5 days
|
Outcome Measures
Primary Outcome Measures
- opoid use post knee/hip arthroplasty [post-op period]
Secondary Outcome Measures
- incidence of visual analogue scale scores greater than 4 [post-op period]
Eligibility Criteria
Criteria
Ages Eligible for Study:
70 Years
and Older
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph's Health Care | London | Ontario | Canada | N6A 4V2 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Ngozi Imasogie, MD, Lawson Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00665262
Other Study ID Numbers:
- R-06-159
- 12177
First Posted:
Apr 23, 2008
Last Update Posted:
Aug 28, 2017
Last Verified:
Aug 1, 2017