Trial Outcomes & Findings for Sub-dissociative Dose Ketamine Dosing Study (NCT NCT03714620)
NCT ID: NCT03714620
Last Updated: 2022-08-09
Results Overview
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
30 minutes
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
Low Dose Group
0.15 mg/kg dose of intravenous ketamine
|
High Dose Group
0.3 mg/kg dose of intravenous ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sub-dissociative Dose Ketamine Dosing Study
Baseline characteristics by cohort
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
37 years
n=7 Participants
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Co-morbidities
Diabetes
|
13 participants
n=5 Participants
|
3 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Co-morbidities
Hypertension
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Co-morbidities
Cancer
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Co-morbidities
Anxiety
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Co-morbidities
Heart Failure
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Co-morbidities
Depression
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Co-morbidities
Obesity
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Weight
|
85 kilograms
n=5 Participants
|
84 kilograms
n=7 Participants
|
84 kilograms
n=5 Participants
|
|
Type of Pain
Flank
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Type of Pain
Back
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Type of Pain
Musculoskeletal
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Type of Pain
Headache
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Type of Pain
Abdominal
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Duration of Pain
<24 hours
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Duration of Pain
2 days
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Duration of Pain
3-7 days
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesChange in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
|
3.8 score on a scale
Interval 3.0 to 4.7
|
3.5 score on a scale
Interval 2.7 to 4.3
|
SECONDARY outcome
Timeframe: 15 minutesChange in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=48 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Change in Pain Score From Baseline to 15 Minutes
|
3.6 score on a scale
Interval 2.7 to 4.4
|
4.8 score on a scale
Interval 4.0 to 5.6
|
SECONDARY outcome
Timeframe: 60 minutesChange in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Change in Pain Score From Baseline to 60 Minutes
|
3.7 score on a scale
Interval 2.9 to 4.6
|
3.5 score on a scale
Interval 2.6 to 4.4
|
SECONDARY outcome
Timeframe: 30 minutesPatient request for additional pain medications at 30 minutes post initiation of drug administration
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Number of Participants Who Need Additional Pain Medication at 30 Minutes
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 minutesPatient request for additional pain medications at 60 minutes
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Number of Patients Who Need Rescue Medications at 60 Minutes
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 minutesPatients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Outcome measures
| Measure |
0.15 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 Participants
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
Adverse Effects at 30 Min
Discomfort
|
15 participants
|
21 participants
|
|
Adverse Effects at 30 Min
Fatigue
|
18 participants
|
20 participants
|
|
Adverse Effects at 30 Min
Dizziness
|
21 participants
|
16 participants
|
|
Adverse Effects at 30 Min
Headache
|
16 participants
|
11 participants
|
|
Adverse Effects at 30 Min
Feeling of Unreality
|
8 participants
|
6 participants
|
|
Adverse Effects at 30 Min
Hearing Changes
|
0 participants
|
2 participants
|
|
Adverse Effects at 30 Min
Vision Changes
|
4 participants
|
6 participants
|
|
Adverse Effects at 30 Min
Mood Alteration
|
4 participants
|
6 participants
|
|
Adverse Effects at 30 Min
Hallucinations
|
2 participants
|
3 participants
|
Adverse Events
0.15 mg/kg IV Ketamine
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
0.3 mg/kg IV Ketamine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.15 mg/kg IV Ketamine
n=49 participants at risk
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
0.3 mg/kg IV Ketamine
n=49 participants at risk
Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
|
|---|---|---|
|
General disorders
Fatigue
|
36.7%
18/49 • Number of events 18 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
40.8%
20/49 • Number of events 20 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
Nervous system disorders
Dizziness
|
42.9%
21/49 • Number of events 21 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
32.7%
16/49 • Number of events 16 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
General disorders
Headache
|
32.7%
16/49 • Number of events 16 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
22.4%
11/49 • Number of events 11 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
General disorders
Feeling of Unreality
|
16.3%
8/49 • Number of events 8 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
12.2%
6/49 • Number of events 6 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
Ear and labyrinth disorders
Hearing Changes
|
0.00%
0/49 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
4.1%
2/49 • Number of events 2 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
Eye disorders
Vision Changes
|
8.2%
4/49 • Number of events 4 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
12.2%
6/49 • Number of events 6 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
Psychiatric disorders
Mood Alteration
|
8.2%
4/49 • Number of events 4 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
12.2%
6/49 • Number of events 6 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
General disorders
Discomfort
|
32.7%
16/49 • Number of events 16 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
42.9%
21/49 • Number of events 21 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
|
Psychiatric disorders
Hallucinations
|
4.1%
2/49 • Number of events 2 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
6.1%
3/49 • Number of events 3 • 60 minutes
The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
|
Additional Information
Shannon Lovett, MD, Associate Professor of Emergency Medicine
Trinity Health, Loyola University Medical Center, Stritch School of Medicine
Phone: 7082168705
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place