Pain, Post Operative Pain
Conditions
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.
Interventions
DRUGKetamine
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.
DRUGSaline
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.
Sponsors
National University, Rwanda
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain as Measured on a 11-point Numerical Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Hallucination | From end of surgery until 60 hours postoperative. | Presence (or not) of hallucinations. |
Countries
Rwanda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 30 |
| 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.
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. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Saline | Total | Ketamine |
|---|---|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 10.8 | 38.7 years STANDARD_DEVIATION 12.1 | 42.2 years STANDARD_DEVIATION 12.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Rwanda | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 24 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 11 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
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.
Time frame: The average of twice daily pain scores, from end of surgery until 60 hours postoperative.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | Postoperative Pain as Measured on a 11-point Numerical Rating Scale | 3.5 units on a scale | Standard Deviation 1.4 |
| Saline | Postoperative Pain as Measured on a 11-point Numerical Rating Scale | 4.9 units on a scale | Standard Deviation 1.6 |
p-value: 0.00995% CI: [0.29, 1.9]t-test, 2 sided
Secondary
Hallucination
Presence (or not) of hallucinations.
Time frame: From end of surgery until 60 hours postoperative.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine | Hallucination | hallucinations | 11 Participants |
| Ketamine | Hallucination | no hallucination | 19 Participants |
| Saline | Hallucination | no hallucination | 29 Participants |
| Saline | Hallucination | hallucinations | 0 Participants |
p-value: <0.00195% CI: [0.18, 0.54]Fisher Exact