Trial Outcomes & Findings for Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department (NCT NCT02916927)
NCT ID: NCT02916927
Last Updated: 2020-04-17
Results Overview
The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
0 - 60 minutes
Results posted on
2020-04-17
Participant Flow
62 rather than 56 patients were enrolled because we were concerned about participants not completing the study.
Participant milestones
| Measure |
Ketamine IV Infusion
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
Received Study Drug
|
31
|
29
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Ketamine IV Infusion
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Overall Study
Discharged prior to study drug receipt
|
0
|
2
|
|
Overall Study
At radiology for 45 & 60 min time points
|
0
|
1
|
|
Overall Study
Withdrawal before first time point
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketamine IV Infusion
n=31 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 12.0 • n=31 Participants
|
46.6 years
STANDARD_DEVIATION 15.4 • n=29 Participants
|
43.2 years
STANDARD_DEVIATION 14.1 • n=60 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=31 Participants
|
20 Participants
n=29 Participants
|
38 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
9 Participants
n=29 Participants
|
22 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Pain numeric rating scale at time 0
|
8.6 units on a scale
STANDARD_DEVIATION 1.6 • n=31 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 1.4 • n=29 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 1.5 • n=60 Participants
|
PRIMARY outcome
Timeframe: 0 - 60 minutesPopulation: There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.
The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.
Outcome measures
| Measure |
Ketamine IV Infusion
n=30 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Side Effects
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60 minutesPopulation: 1 patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points. There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.
The difference in percentage of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.
Outcome measures
| Measure |
Ketamine IV Infusion
n=30 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Side Effects
5 minutes
|
10 participants
|
20 participants
|
|
Side Effects
10 minutes
|
17 participants
|
18 participants
|
|
Side Effects
15 minutes
|
16 participants
|
15 participants
|
|
Side Effects
20 minutes
|
13 participants
|
12 participants
|
|
Side Effects
30 minutes
|
13 participants
|
9 participants
|
|
Side Effects
45 minutes
|
9 participants
|
5 participants
|
|
Side Effects
60 minutes
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60 minutesPopulation: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points. There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.
The difference in severity of side effects (0 - 4) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 indicates no side effects and 4 most severe side effects.
Outcome measures
| Measure |
Ketamine IV Infusion
n=30 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Side Effect Severity
Fatigue at 5 minutes
|
0.4 units on a scale
Interval 0.03 to 0.8
|
0.6 units on a scale
Interval -0.05 to 1.1
|
|
Side Effect Severity
Fatigue at 10 minutes
|
0.9 units on a scale
Interval 0.4 to 1.4
|
0.7 units on a scale
Interval 0.3 to 1.2
|
|
Side Effect Severity
Fatigue at 15 minutes
|
.6 units on a scale
Interval 0.2 to 1.0
|
0.7 units on a scale
Interval 0.2 to 1.2
|
|
Side Effect Severity
Fatigue at 20 minutes
|
0.5 units on a scale
Interval -0.1 to 0.9
|
0.4 units on a scale
Interval 0.1 to 0.8
|
|
Side Effect Severity
Fatigue at 30 minutes
|
0.2 units on a scale
Interval 0.0 to 0.4
|
0.3 units on a scale
Interval -0.1 to 0.8
|
|
Side Effect Severity
Fatigue at 45 minutes
|
0.3 units on a scale
Interval -0.1 to 0.7
|
0.4 units on a scale
Interval -0.1 to 0.8
|
|
Side Effect Severity
Fatigue at 60 minutes
|
0.3 units on a scale
Interval -0.1 to 0.6
|
0.5 units on a scale
Interval 0.0 to 0.9
|
|
Side Effect Severity
Dizziness at 5 minutes
|
0.8 units on a scale
Interval 0.3 to 1.2
|
2.2 units on a scale
Interval 1.6 to 2.9
|
|
Side Effect Severity
Dizziness at 10 minutes
|
1.1 units on a scale
Interval 0.6 to 1.7
|
1.9 units on a scale
Interval 1.3 to 2.5
|
|
Side Effect Severity
Dizziness at 15 minutes
|
1.1 units on a scale
Interval 0.6 to 1.6
|
1.1 units on a scale
Interval 0.6 to 1.7
|
|
Side Effect Severity
Dizziness at 20 minutes
|
1.0 units on a scale
Interval 0.5 to 1.5
|
0.9 units on a scale
Interval 0.5 to 1.3
|
|
Side Effect Severity
Dizziness at 30 minutes
|
0.4 units on a scale
Interval 0.1 to 0.6
|
0.4 units on a scale
Interval 0.1 to 0.8
|
|
Side Effect Severity
Dizziness at 45 minutes
|
0.2 units on a scale
Interval -1.0 to 0.5
|
0.3 units on a scale
Interval 0.0 to 0.7
|
|
Side Effect Severity
Dizziness at 60 minutes
|
0.2 units on a scale
Interval -0.1 to 0.4
|
0.3 units on a scale
Interval 0.0 to 0.7
|
|
Side Effect Severity
Headache at 5 minutes
|
0.2 units on a scale
Interval 0.0 to 0.4
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Headache at 10 minutes
|
0.1 units on a scale
Interval 0.0 to 0.2
|
0.3 units on a scale
Interval 0.0 to 0.6
|
|
Side Effect Severity
Headache at 15 minutes
|
0.3 units on a scale
Interval 0.0 to 0.6
|
0.3 units on a scale
Interval -0.1 to 0.6
|
|
Side Effect Severity
Headache at 20 minutes
|
0.2 units on a scale
Interval -0.1 to 0.5
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Headache at 30 minutes
|
0.3 units on a scale
Interval -0.1 to 0.7
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Headache at 45 minutes
|
0.2 units on a scale
Interval -0.1 to 0.5
|
0.3 units on a scale
Interval -0.1 to 0.6
|
|
Side Effect Severity
Headache at 60 minutes
|
0.2 units on a scale
Interval -0.1 to 0.5
|
0.3 units on a scale
Interval -0.1 to 0.6
|
|
Side Effect Severity
Unreality at 5 minutes
|
0.9 units on a scale
Interval 0.4 to 1.4
|
2.6 units on a scale
Interval 1.9 to 3.2
|
|
Side Effect Severity
Unreality at 10 minutes
|
1.5 units on a scale
Interval 1.0 to 2.0
|
2.2 units on a scale
Interval 1.6 to 2.8
|
|
Side Effect Severity
Unreality at 15 minutes
|
1.4 units on a scale
Interval 0.9 to 1.9
|
1.3 units on a scale
Interval 0.8 to 1.8
|
|
Side Effect Severity
Unreality at 20 minutes
|
1.1 units on a scale
Interval 0.7 to 1.5
|
0.8 units on a scale
Interval 0.4 to 1.1
|
|
Side Effect Severity
Unreality at 30 minutes
|
0.5 units on a scale
Interval 0.2 to 0.8
|
0.2 units on a scale
Interval 0.0 to 0.3
|
|
Side Effect Severity
Unreality at 45 minutes
|
0.2 units on a scale
Interval -0.1 to 0.5
|
0.1 units on a scale
Interval 0.0 to 0.2
|
|
Side Effect Severity
Unreality at 60 minutes
|
0.1 units on a scale
Interval 0.0 to 0.2
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Hearing at 5 minutes
|
0.1 units on a scale
Interval -0.1 to 0.3
|
0.6 units on a scale
Interval 0.1 to 1.1
|
|
Side Effect Severity
Hearing at 10 minutes
|
0.3 units on a scale
Interval 0.0 to 0.7
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Hearing at 15 minutes
|
0.3 units on a scale
Interval 0.0 to 0.7
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Hearing at 20 minutes
|
0.4 units on a scale
Interval 0.0 to 0.8
|
0.1 units on a scale
Interval -0.1 to 0.3
|
|
Side Effect Severity
Hearing at 30 minutes
|
0.2 units on a scale
Interval -0.1 to 0.4
|
0.1 units on a scale
Interval -0.1 to 0.4
|
|
Side Effect Severity
Hearing at 45 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Hearing at 60 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0.04 units on a scale
Interval -0.02 to 0.05
|
|
Side Effect Severity
Vision at 5 minutes
|
0.03 units on a scale
Interval -0.03 to 0.1
|
0.7 units on a scale
Interval 0.1 to 1.2
|
|
Side Effect Severity
Vision at 10 minutes
|
0.2 units on a scale
Interval 0.0 to 0.4
|
0.4 units on a scale
Interval -0.1 to 0.8
|
|
Side Effect Severity
Vision at 15 minutes
|
0.2 units on a scale
Interval 0.0 to 0.4
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Vision at 20 minutes
|
0.1 units on a scale
Interval -0.1 to 0.3
|
0.1 units on a scale
Interval -0.1 to 0.2
|
|
Side Effect Severity
Vision at 30 minutes
|
0.1 units on a scale
Interval -0.1 to 0.2
|
0.03 units on a scale
Interval -0.04 to 0.1
|
|
Side Effect Severity
Vision at 45 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Vision at 60 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Mood at 5 minutes
|
0.8 units on a scale
Interval 0.3 to 1.3
|
1.7 units on a scale
Interval 1.0 to 2.3
|
|
Side Effect Severity
Mood at 10 minutes
|
1.2 units on a scale
Interval 0.7 to 1.7
|
2.3 units on a scale
Interval 1.6 to 2.9
|
|
Side Effect Severity
Mood at 15 minutes
|
1.4 units on a scale
Interval 0.9 to 1.8
|
2.0 units on a scale
Interval 1.3 to 2.6
|
|
Side Effect Severity
Mood at 20 minutes
|
1.2 units on a scale
Interval 0.8 to 1.7
|
1.2 units on a scale
Interval 0.7 to 1.7
|
|
Side Effect Severity
Mood at 30 minutes
|
0.9 units on a scale
Interval 0.5 to 1.3
|
0.6 units on a scale
Interval 0.2 to 1.0
|
|
Side Effect Severity
Mood at 45 minutes
|
0.6 units on a scale
Interval 0.2 to 1.0
|
0.3 units on a scale
Interval 0.0 to 0.6
|
|
Side Effect Severity
Mood at 60 minutes
|
0.3 units on a scale
Interval 0.1 to 0.6
|
0.1 units on a scale
Interval -0.1 to 0.3
|
|
Side Effect Severity
Discomfort at 5 minutes
|
0.1 units on a scale
Interval -0.1 to 0.3
|
0.4 units on a scale
Interval 0.0 to 0.9
|
|
Side Effect Severity
Discomfort at 10 minutes
|
0.1 units on a scale
Interval 0.0 to 0.2
|
0.4 units on a scale
Interval -0.1 to 0.9
|
|
Side Effect Severity
Discomfort at 15 minutes
|
0.1 units on a scale
Interval 0.0 to 0.3
|
1.0 units on a scale
Interval 0.8 to 1.9
|
|
Side Effect Severity
Discomfort at 20 minutes
|
0.2 units on a scale
Interval -0.1 to 0.4
|
0.4 units on a scale
Interval 0.0 to 0.8
|
|
Side Effect Severity
Discomfort at 30 minutes
|
0.1 units on a scale
Interval 0.0 to 0.3
|
0.3 units on a scale
Interval -0.1 to 0.6
|
|
Side Effect Severity
Discomfort at 45 minutes
|
0.2 units on a scale
Interval -0.1 to 0.4
|
0.2 units on a scale
Interval -0.1 to 0.5
|
|
Side Effect Severity
Discomfort at 60 minutes
|
0.2 units on a scale
Interval -0.1 to 0.5
|
0.3 units on a scale
Interval -0.1 to 0.7
|
|
Side Effect Severity
Hallucinations at 5 minutes
|
0.03 units on a scale
Interval 0.0 to 0.1
|
0.9 units on a scale
Interval 0.4 to 1.5
|
|
Side Effect Severity
Hallucinations at 10 minutes
|
0.1 units on a scale
Interval -0.1 to 0.2
|
0.7 units on a scale
Interval 0.1 to 1.2
|
|
Side Effect Severity
Hallucinations at 15 minutes
|
0.03 units on a scale
Interval 0.0 to 0.1
|
0.4 units on a scale
Interval 0.0 to 0.7
|
|
Side Effect Severity
Hallucinations at 20 minutes
|
0.1 units on a scale
Interval -0.1 to 0.4
|
0.1 units on a scale
Interval 0.0 to 0.2
|
|
Side Effect Severity
Hallucinations at 30 minutes
|
0.1 units on a scale
Interval -0.1 to 0.4
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Hallucinations at 45 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Side Effect Severity
Hallucinations at 60 minutes
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60 minutesPopulation: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points. There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.
The difference in how bothersome (0, not bothersome, to 4, very bothersome, on the Side Effect Rating Scale for Dissociative Anesthetics "SERSDA") the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes. "0" (no side effects), "1" (weak), "2" (moderate), "3" ("bothersome") to "4" (very bothersome)
Outcome measures
| Measure |
Ketamine IV Infusion
n=30 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
How Bothersome Are the Side Effects?
Fatigue at 5 minutes
|
0.1 score on a scale
Interval 0.0 to 0.3
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Fatigue at 10 minutes
|
0.4 score on a scale
Interval 0.1 to 0.8
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Fatigue at 15 minutes
|
0.3 score on a scale
Interval 0.0 to 0.5
|
0.2 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Fatigue at 20 minutes
|
0.3 score on a scale
Interval 0.0 to 0.6
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Fatigue at 30 minutes
|
0.1 score on a scale
Interval 0.0 to 0.3
|
0.2 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Fatigue at 45 minutes
|
0.2 score on a scale
Interval -0.1 to 0.5
|
0.1 score on a scale
Interval -0.2 to 0.4
|
|
How Bothersome Are the Side Effects?
Fatigue at 60 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.3 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Dizziness at 5 minutes
|
0.5 score on a scale
Interval 0.1 to 0.9
|
1.4 score on a scale
Interval 0.7 to 2.1
|
|
How Bothersome Are the Side Effects?
Dizziness at 10 minutes
|
0.6 score on a scale
Interval 0.2 to 1.1
|
0.9 score on a scale
Interval 0.4 to 1.5
|
|
How Bothersome Are the Side Effects?
Dizziness at 15 minutes
|
0.5 score on a scale
Interval 0.1 to 0.9
|
0.7 score on a scale
Interval 0.2 to 1.1
|
|
How Bothersome Are the Side Effects?
Dizziness at 20 minutes
|
0.5 score on a scale
Interval 0.0 to 0.9
|
0.6 score on a scale
Interval 0.1 to 1.0
|
|
How Bothersome Are the Side Effects?
Dizziness at 30 minutes
|
0.3 score on a scale
Interval 0.0 to 0.6
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Dizziness at 45 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Dizziness at 60 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Headache at 5 minutes
|
0.2 score on a scale
Interval 0.0 to 0.4
|
0.1 score on a scale
Interval -0.1 to 0.4
|
|
How Bothersome Are the Side Effects?
Headache at 10 minutes
|
0.1 score on a scale
Interval 0.0 to 0.2
|
0.2 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Headache at 15 minutes
|
0.2 score on a scale
Interval -0.1 to 0.5
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Headache at 20 minutes
|
0.1 score on a scale
Interval 0.0 to 0.2
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Headache at 30 minutes
|
0.2 score on a scale
Interval -0.1 to 0.5
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Headache at 45 minutes
|
0.2 score on a scale
Interval -0.1 to 0.5
|
0.3 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Headache at 60 minutes
|
0.1 score on a scale
Interval 0.0 to 0.3
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Unreality at 5 minutes
|
0.3 score on a scale
Interval 0.0 to 0.6
|
1.6 score on a scale
Interval 1.0 to 2.3
|
|
How Bothersome Are the Side Effects?
Unreality at 10 minutes
|
0.6 score on a scale
Interval 0.1 to 1.0
|
0.9 score on a scale
Interval 0.4 to 1.5
|
|
How Bothersome Are the Side Effects?
Unreality at 15 minutes
|
0.5 score on a scale
Interval 0.1 to 1.0
|
0.4 score on a scale
Interval 0.0 to 0.8
|
|
How Bothersome Are the Side Effects?
Unreality at 20 minutes
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0.1 score on a scale
Interval 0.0 to 0.2
|
|
How Bothersome Are the Side Effects?
Unreality at 30 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.03 score on a scale
Interval 0.0 to 0.1
|
|
How Bothersome Are the Side Effects?
Unreality at 45 minutes
|
0.1 score on a scale
Interval -0.1 to 0.4
|
0.03 score on a scale
Interval 0.0 to 0.1
|
|
How Bothersome Are the Side Effects?
Unreality at 60 minutes
|
0.03 score on a scale
Interval 0.0 to 0.1
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Hearing at 5 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Hearing at 10 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.1 score on a scale
Interval -0.1 to 0.4
|
|
How Bothersome Are the Side Effects?
Hearing at 15 minutes
|
0.1 score on a scale
Interval -0.1 to 0.3
|
0.1 score on a scale
Interval 0.0 to 0.2
|
|
How Bothersome Are the Side Effects?
Hearing at 20 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.2 score on a scale
Interval -0.1 to 0.5
|
|
How Bothersome Are the Side Effects?
Hearing at 30 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.1 score on a scale
Interval -0.1 to 0.4
|
|
How Bothersome Are the Side Effects?
Hearing at 45 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Hearing at 60 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0.04 score on a scale
Interval 0.0 to 0.1
|
|
How Bothersome Are the Side Effects?
Vision at 5 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Vision at 10 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Vision at 15 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.1 score on a scale
Interval -0.1 to 0.4
|
|
How Bothersome Are the Side Effects?
Vision at 20 minutes
|
0.1 score on a scale
Interval -0.1 to 0.3
|
0.1 score on a scale
Interval -0.01 to 0.4
|
|
How Bothersome Are the Side Effects?
Vision at 30 minutes
|
0.1 score on a scale
Interval -0.1 to 0.4
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Vision at 45 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Vision at 60 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Mood at 5 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.5 score on a scale
Interval 0.0 to 0.9
|
|
How Bothersome Are the Side Effects?
Mood at 10 minutes
|
0.2 score on a scale
Interval 0.0 to 0.5
|
0.3 score on a scale
Interval 0.0 to 0.6
|
|
How Bothersome Are the Side Effects?
Mood at 15 minutes
|
0.2 score on a scale
Interval 0.0 to 0.4
|
0.4 score on a scale
Interval 0.0 to 0.8
|
|
How Bothersome Are the Side Effects?
Mood at 20 minutes
|
0.2 score on a scale
Interval 0.0 to 0.4
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Mood at 30 minutes
|
0.2 score on a scale
Interval 0.0 to 0.5
|
0.03 score on a scale
Interval 0.0 to 0.1
|
|
How Bothersome Are the Side Effects?
Mood at 45 minutes
|
0.3 score on a scale
Interval -0.1 to 0.6
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Mood at 60 minutes
|
0.1 score on a scale
Interval -0.1 to 0.4
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Discomfort at 5 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.4 score on a scale
Interval 0.0 to 0.9
|
|
How Bothersome Are the Side Effects?
Discomfort at 10 minutes
|
0.1 score on a scale
Interval 0.0 to 0.2
|
0.4 score on a scale
Interval -0.1 to 0.9
|
|
How Bothersome Are the Side Effects?
Discomfort at 15 minutes
|
0.1 score on a scale
Interval 0.0 to 0.2
|
0.4 score on a scale
Interval 0.0 to 0.8
|
|
How Bothersome Are the Side Effects?
Discomfort at 20 minutes
|
0.03 score on a scale
Interval 0.0 to 0.1
|
0.4 score on a scale
Interval 0.0 to 0.8
|
|
How Bothersome Are the Side Effects?
Discomfort at 30 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.3 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Discomfort at 45 minutes
|
0.2 score on a scale
Interval -0.1 to 0.4
|
0.3 score on a scale
Interval -0.1 to 0.6
|
|
How Bothersome Are the Side Effects?
Discomfort at 60 minutes
|
0.2 score on a scale
Interval -0.1 to 0.5
|
0.3 score on a scale
Interval -0.1 to 0.7
|
|
How Bothersome Are the Side Effects?
Hallucinations at 5 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0.8 score on a scale
Interval 0.2 to 1.3
|
|
How Bothersome Are the Side Effects?
Hallucinations at 10 minutes
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.5 score on a scale
Interval 0.0 to 0.9
|
|
How Bothersome Are the Side Effects?
Hallucinations at 15 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0.3 score on a scale
Interval 0.0 to 0.6
|
|
How Bothersome Are the Side Effects?
Hallucinations at 20 minutes
|
0.1 score on a scale
Interval -0.1 to 0.4
|
0.1 score on a scale
Interval 0.0 to 0.2
|
|
How Bothersome Are the Side Effects?
Hallucinations at 30 minutes
|
0.1 score on a scale
Interval -0.1 to 0.4
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Hallucinations at 45 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
How Bothersome Are the Side Effects?
Hallucinations at 60 minutes
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 5, 10 , 15, 20, 30, 45, 60 minutesPopulation: One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points. There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.
The difference in pain numeric rating score (NRS 0-10) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. Pain numeric rating scale from 0 (no pain) to 10 (maximal pain).
Outcome measures
| Measure |
Ketamine IV Infusion
n=30 Participants
Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV Infusion: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
|
Ketamine IV Push
n=29 Participants
Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.
Ketamine IV push: Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
|
|---|---|---|
|
Reduction in Pain on Numeric Rating Scale.
5 minutes
|
6.5 score on a scale
Interval 5.4 to 7.7
|
2.9 score on a scale
Interval 1.5 to 4.3
|
|
Reduction in Pain on Numeric Rating Scale.
10 minutes
|
5.4 score on a scale
Interval 4.2 to 6.5
|
2.8 score on a scale
Interval 1.5 to 4.1
|
|
Reduction in Pain on Numeric Rating Scale.
15 minutes
|
4.7 score on a scale
Interval 3.6 to 5.7
|
3.4 score on a scale
Interval 2.1 to 4.7
|
|
Reduction in Pain on Numeric Rating Scale.
20 minutes
|
4.3 score on a scale
Interval 3.2 to 5.4
|
3.9 score on a scale
Interval 2.7 to 5.1
|
|
Reduction in Pain on Numeric Rating Scale.
30 minutes
|
4.8 score on a scale
Interval 3.8 to 5.9
|
4.2 score on a scale
Interval 3.0 to 5.5
|
|
Reduction in Pain on Numeric Rating Scale.
45 minutes
|
5.3 score on a scale
Interval 4.3 to 6.3
|
4.6 score on a scale
Interval 3.2 to 5.9
|
|
Reduction in Pain on Numeric Rating Scale.
60 minutes
|
5.4 score on a scale
Interval 4.4 to 6.5
|
4.5 score on a scale
Interval 3.2 to 5.7
|
Adverse Events
Ketamine IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine IV Push
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Herring
Alameda Health Systemt - Highland Hospital
Phone: (510) 437-4564
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place