Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

University of Saskatchewan61 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post Operative Pain Pain

Interventions

KetamineDRUG

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.

SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rwanda

Kigali, Rwanda

Outcomes

Primary Outcomes

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.

Time frame: The average of twice daily pain scores, from end of surgery until 60 hours postoperative.

Secondary Outcomes

Hallucination

Presence (or not) of hallucinations.

Time frame: From end of surgery until 60 hours postoperative.

Data from ClinicalTrials.gov

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