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Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

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ClinicalTrials.gov Identifier: NCT02514122
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
National University, Rwanda
Information provided by (Responsible Party):
William McKay, 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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Pain Drug: Ketamine Drug: Saline Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
Study Start Date : June 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Hallucination [ Time Frame: From end of surgery until 60 hours postoperative. ]
    Presence (or not) of hallucinations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514122


Locations
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Rwanda
University of Rwanda
Kigali, Rwanda, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
National University, Rwanda
Investigators
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Principal Investigator: William Mckay, MD University of Saskatchewan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William McKay, MD FRCPC, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02514122    
Other Study ID Numbers: Bio# 14-193
First Posted: August 3, 2015    Key Record Dates
Results First Posted: November 9, 2018
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action