Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Brief Summary
A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.
Condition or Disease
- Post Operative Pain
- Pain
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | Has Results |
Age: | 18 Years to 60 Years (Adult) |
Enrollment: | 61 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Jun 15, 2020 | |
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Primary Completion: | Jul 15, 2020 | |
Completion Date: | Jul 15, 2020 | |
Study First Posted: | Aug 03, 2015 | |
Results First Posted: | Nov 09, 2018 | |
Last Updated: | Nov 09, 2018 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
A randomized double blind control trial. All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary outcome will be a reduction in mean Pain Scores using parametric statistical analysis to discriminate significance. Pain will be measured using an 11-point numerical rating scale. Secondary outcomes will be the presence of significant side effects. This trial is a partnership between the University of Saskatchewan and the National University of Rwanda with ethics approval from each institutions ethics board.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 60 |
More Details
NCT Number: | NCT02514122 |
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Other IDs: | Bio# 14-193 |
Study URL: | https://ClinicalTrials.gov/show/NCT02514122 |
Last updated: Jun 17, 2022