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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02514122
Study type Interventional
Source University of Saskatchewan
Contact
Status Completed
Phase Phase 2/Phase 3
Start date June 2015
Completion date July 2015

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