NCT02514122

Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post Operative Pain
• Pain

Interventions

Type	Name	Description
DRUG	Ketamine	Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
DRUG	Saline	Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-08-03
• Last updated: 2018-11-09
• Results posted: 2018-11-09

Locations

1 site across 1 country: Rwanda