Trial Outcomes & Findings for Ketamine For Acute Treatment of Pain in Emergency Department (NCT NCT02306759)
NCT ID: NCT02306759
Last Updated: 2017-08-09
Results Overview
Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
15 minutes after administration of study intervention
Results posted on
2017-08-09
Participant Flow
This was a single-center, prospective, randomized, double-blind, placebo-controlled trial comparing the use of SDDK versus placebo as an adjunct therapy for moderate to severe acute pain in the ED. The study was conducted in a community teaching hospital with a level-2 trauma ED where more than 77,000 patients are treated annually.
Participant milestones
| Measure |
Treatment
Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine For Acute Treatment of Pain in Emergency Department
Baseline characteristics by cohort
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 16 • n=5 Participants
|
48 years
STANDARD_DEVIATION 17 • n=7 Participants
|
44 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after administration of study interventionChange from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.
Outcome measures
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
|
3.5 units on a scale
Interval 1.0 to 7.3
|
6.0 units on a scale
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: during the study periodPopulation: Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine.
Incidence or number of participants with adverse events.
Outcome measures
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: At the end of study periodPatient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.
Outcome measures
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
Patient Satisfaction of Pain Control Based on a Likert Scale
|
8.57 units on a scale
Standard Deviation 2.1
|
6.05 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)Outcome measures
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
Mean Consumption of Rescue Analgesia
T5
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Mean Consumption of Rescue Analgesia
T15
|
0.23 milligrams
Standard Deviation 1.3
|
0.14 milligrams
Standard Deviation 0.74
|
|
Mean Consumption of Rescue Analgesia
T30
|
0.37 milligrams
Standard Deviation 1.45
|
0.28 milligrams
Standard Deviation 1.03
|
|
Mean Consumption of Rescue Analgesia
T45
|
0.07 milligrams
Standard Deviation 0.37
|
0 milligrams
Standard Deviation 0
|
|
Mean Consumption of Rescue Analgesia
T60
|
0 milligrams
Standard Deviation 0
|
0.22 milligrams
Standard Deviation 1.15
|
|
Mean Consumption of Rescue Analgesia
T75
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Mean Consumption of Rescue Analgesia
T90
|
0.48 milligrams
Standard Deviation 1.66
|
0 milligrams
Standard Deviation 0
|
|
Mean Consumption of Rescue Analgesia
T105
|
0.55 milligrams
Standard Deviation 1.87
|
0.42 milligrams
Standard Deviation 1.26
|
|
Mean Consumption of Rescue Analgesia
T120
|
0 milligrams
Standard Deviation 0
|
0.42 milligrams
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: throughout study completionED Length of stay (minutes) throughout study period
Outcome measures
| Measure |
Treatment
n=30 Participants
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
|
Placebo
n=30 Participants
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
|
|---|---|---|
|
ED Length of Stay (Minutes)
|
267 minutes
Standard Deviation 191
|
292 minutes
Standard Deviation 203
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=30 participants at risk
Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
|
Placebo
n=30 participants at risk
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
|
|---|---|---|
|
Nervous system disorders
Dreams
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1
|
10.0%
3/30 • Number of events 3
|
Additional Information
Director, Emergency Medicine Clinical Research Program
The Brooklyn Hospital Center
Phone: 718-250-6250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place