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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Saline

Condition or Disease

  • Post Operative Pain
  • Pain

Phase

Study Design

Study type: Interventional
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
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
Minimum Age: 18
Maximum Age: 60

More Details

NCT Number: NCT02514122
Other IDs: Bio# 14-193
Study URL: https://ClinicalTrials.gov/show/NCT02514122
Last updated: Jun 17, 2022