Trial Outcomes & Findings for Ketamine: Comparison of IV Push vs. IV Drip (NCT NCT02363270)
NCT ID: NCT02363270
Last Updated: 2017-11-22
Results Overview
Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
30 minutes
Results posted on
2017-11-22
Participant Flow
Participant milestones
| Measure |
IV Push Group
Ketamine medication given via IV Push. IV Push is the intervention.
Ketamine: IV Push or or IV Drip
|
IV Drip Group
Ketamine medication given via IV Drip. IV Drip is the intervention.
Ketamine: IV Push or or IV Drip
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine: Comparison of IV Push vs. IV Drip
Baseline characteristics by cohort
| Measure |
IV Push Group
n=24 Participants
Ketamine medication given via IV Push. IV Push is the intervention.
Ketamine: IV Push or or IV Drip
|
IV Drip Group
n=24 Participants
Ketamine medication given via IV Drip. IV Drip is the intervention.
Ketamine: IV Push or or IV Drip
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.25 years
STANDARD_DEVIATION 15.12 • n=5 Participants
|
43.56 years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
44.40 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesOverall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
Outcome measures
| Measure |
IV Push Group
n=24 Participants
Ketamine medication given via IV Push. IV Push is the intervention.
Ketamine: IV Push or or IV Drip
|
IV Drip Group
n=24 Participants
Ketamine medication given via IV Drip. IV Drip is the intervention.
Ketamine: IV Push or or IV Drip
|
|---|---|---|
|
Overall Rate of Feeling Unreality
|
22 Participants
|
13 Participants
|
Adverse Events
IV Push Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
IV Drip Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Push Group
n=24 participants at risk
Ketamine medication given via IV Push. IV Push is the intervention.
Ketamine: IV Push or or IV Drip
|
IV Drip Group
n=24 participants at risk
Ketamine medication given via IV Drip. IV Drip is the intervention.
Ketamine: IV Push or or IV Drip
|
|---|---|---|
|
Nervous system disorders
Feeling of Unreality
|
91.7%
22/24 • 120 minutes
|
54.2%
13/24 • 120 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place