Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

University of Saskatchewan

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain; Post Operative Pain

Treatments: Drug: Saline; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02514122

Bio# 14-193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission

Exclusion criteria

• Allergy to Ketamine
• History of narcotic abuse or dependence
• Those patients for which decreased cognitive function is a barrier to accurate data collection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Ketamine

Experimental group

Description:

Participants will receive subcutaneous ketamine (1mg/kg) 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.

Treatment:

Drug: Ketamine

Saline

Placebo Comparator group

Description:

Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.

Treatment:

Drug: Saline