Trial Outcomes & Findings for Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda (NCT NCT02514122)

NCT ID: NCT02514122

Last Updated: 2018-11-09

Results Overview

Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 61 participants
• Primary outcome timeframe: The average of twice daily pain scores, from end of surgery until 60 hours postoperative.
• Results posted on: 2018-11-09

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	32	29
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ketamine n=30 Participants 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.	Saline n=29 Participants 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 n=59 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 12.6 • n=30 Participants	35.3 years STANDARD_DEVIATION 10.8 • n=29 Participants	38.7 years STANDARD_DEVIATION 12.1 • n=59 Participants
Sex: Female, Male Female	17 Participants n=30 Participants	18 Participants n=29 Participants	35 Participants n=59 Participants
Sex: Female, Male Male	13 Participants n=30 Participants	11 Participants n=29 Participants	24 Participants n=59 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Rwanda	30 Participants n=30 Participants	29 Participants n=29 Participants	59 Participants n=59 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketamine n=30 Participants 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.	Saline n=29 Participants 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.
Postoperative Pain as Measured on a 11-point Numerical Rating Scale	3.5 units on a scale Standard Deviation 1.4	4.9 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: From end of surgery until 60 hours postoperative.

Presence (or not) of hallucinations.

Outcome measures

Measure	Ketamine n=30 Participants 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.	Saline n=29 Participants 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.
Hallucination hallucinations	11 Participants	0 Participants
Hallucination no hallucination	19 Participants	29 Participants

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketamine n=30 participants at risk 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.	Saline n=30 participants at risk；n=29 participants at risk 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.
Psychiatric disorders hallucination	36.7% 11/30 • Number of events 11 • 2 days	0.00% 0/30 • 2 days

Additional Information

Dr. William P. McKay

University of Saskatchewan

Phone: 1 306 655 1202

Email: bill.mckay@usask.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place