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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post Operative Pain
Pain
Interventions Drug: Ketamine
Drug: Saline
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Saline
Hide Arm/Group 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.

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.

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.

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.
Period Title: Overall Study
Started 32 29
Completed 30 [1] 29
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
[1]
one participant dropped out for religious reasons; one for needle phobia
Arm/Group Title Ketamine Saline Total
Hide Arm/Group 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.

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.

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.

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.

 Total of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 59 participants
42.2  (12.6) 35.3  (10.8) 38.7  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
17
  56.7%
18
  62.1%
35
  59.3%
Male
13
  43.3%
11
  37.9%
24
  40.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Rwanda Number Analyzed 30 participants 29 participants 59 participants
30
 100.0%
29
 100.0%
59
 100.0%
1.Primary Outcome
Title Postoperative Pain as Measured on a 11-point Numerical Rating Scale
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group 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.

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.

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.

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.
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.5  (1.4) 4.9  (1.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Saline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.29 to 1.9
Estimation Comments Score was lower in the Ketamine group.
2.Secondary Outcome
Title Hallucination
Hide Description Presence (or not) of hallucinations.
Time Frame From end of surgery until 60 hours postoperative.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group 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.

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.

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.

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.
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
hallucinations
11
  36.7%
0
   0.0%
no hallucination
19
  63.3%
29
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Saline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value .37
Confidence Interval (2-Sided) 95%
.18 to .54
Estimation Comments [Not Specified]
Time Frame 2 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Saline
Hide Arm/Group 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.

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.

Ketamine participants had more hallucinations than saline group.

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.

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.
All-Cause Mortality
Ketamine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Ketamine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/29 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/30 (36.67%)      0/30 (0.00%)    
Psychiatric disorders     
hallucination †  11/30 (36.67%)  11 0/30 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William P. McKay
Organization: University of Saskatchewan
Phone: 1 306 655 1202
EMail: bill.mckay@usask.ca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: William McKay, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02514122    
Other Study ID Numbers: Bio# 14-193
First Submitted: July 31, 2015
First Posted: August 3, 2015
Results First Submitted: May 12, 2017
Results First Posted: November 9, 2018
Last Update Posted: November 9, 2018