Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Primary Purpose
Post Operative Pain, Pain
Status
Completed
Phase
Phase 2
Locations
Rwanda
Study Type
Interventional
Intervention
Ketamine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility 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
Sites / Locations
- University of Rwanda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hallucination
Presence (or not) of hallucinations.
Full Information
NCT ID
NCT02514122
First Posted
July 31, 2015
Last Updated
November 6, 2018
Sponsor
University of Saskatchewan
Collaborators
National University, Rwanda
1. Study Identification
Unique Protocol Identification Number
NCT02514122
Brief Title
Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Official Title
Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
National University, Rwanda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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 Measure Information:
Title
Postoperative Pain as Measured on a 11-point Numerical Rating Scale
Description
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 Outcome Measure Information:
Title
Hallucination
Description
Presence (or not) of hallucinations.
Time Frame
From end of surgery until 60 hours postoperative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Mckay, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rwanda
City
Kigali
ZIP/Postal Code
S7N 0W8
Country
Rwanda
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.
Citations:
PubMed Identifier
29134517
Citation
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.
Results Reference
derived
Learn more about this trial
Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
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