Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514122
• Other study ID #: Bio# 14-193
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Rwanda	University of Rwanda	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	National University, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain as Measured on a 11-point Numerical Rating Scale	Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.	The average of twice daily pain scores, from end of surgery until 60 hours postoperative.
Secondary	Hallucination	Presence (or not) of hallucinations.	From end of surgery until 60 hours postoperative.