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Completed

NCT Number: NCT02514122

Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Rwanda

Kigali, S7N 0W8, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Drug

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.

Primary outcomes

  1. Postoperative Pain as Measured on a 11-point Numerical Rating Scale

    Time frame: 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 outcomes

  1. Hallucination

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

    Presence (or not) of hallucinations.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • National University, Rwanda

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2015
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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