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Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 3, 2015
Results First Submitted Date  ICMJE May 12, 2017
Results First Posted Date  ICMJE November 9, 2018
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Postoperative Pain relief [ Time Frame: 60 hours ]
Pain will be measured using an 11-point numerical rating scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Hallucination [ Time Frame: From end of surgery until 60 hours postoperative. ]
Presence (or not) of hallucinations.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Drug Side effects [ Time Frame: 60 hours ]
Presence of significant side effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Official Title  ICMJE Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Operative Pain
  • Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Saline
Publications * Sacevich C, Semakuba B, McKay WP, Thakore S, Twagirumugabe T, Nyiligira J. Subcutaneous ketamine for postoperative pain relief in Rwanda: a randomized clinical trial. Can J Anaesth. 2018 Feb;65(2):170-177. doi: 10.1007/s12630-017-1009-7. Epub 2017 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2018)
61
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
25
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Rwanda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514122
Other Study ID Numbers  ICMJE Bio# 14-193
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared.
Responsible Party William McKay, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE National University, Rwanda
Investigators  ICMJE
Principal Investigator: William Mckay, MD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP