Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

Phase 2

Completed

• Conditions: Pain; Post Operative Pain
• Interventions: Drug: Ketamine; Drug: Saline

• Registration Number: NCT02514122
• Lead Sponsor: University of Saskatchewan

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.

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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-03
• Results First Submitted: 2017-05-12
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Results First Posted: 2018-11-09
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	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.
Saline	Saline	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain as Measured on a 11-point Numerical Rating Scale	The average of twice daily pain scores, from end of surgery until 60 hours postoperative.	Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.

Secondary Outcome Measures

Name	Time	Method
Hallucination	From end of surgery until 60 hours postoperative.	Presence (or not) of hallucinations.

Trial Locations

Locations (1)

University of Rwanda; 🇷🇼 Kigali, Rwanda