Trial Outcomes & Findings for Ketamine for Acute Migraine in the Emergency Department (NCT NCT02697071)
NCT ID: NCT02697071
Last Updated: 2021-03-26
Results Overview
NRS (National rating scale) pain score change from baseline following ketamine dose. Minimum score is 0, maximum score is 10, and higher scores mean worse pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
30 minutes
Results posted on
2021-03-26
Participant Flow
Participant milestones
| Measure |
Placebo Control
Patients will receive an equivalent volume of normal saline intravenously.
Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Ketamine
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Acute Migraine in the Emergency Department
Baseline characteristics by cohort
| Measure |
Placebo Control
n=18 Participants
Patients will receive an equivalent volume of normal saline intravenously.
Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Ketamine
n=16 Participants
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
38.5 years
STANDARD_DEVIATION 13.75 • n=107 Participants
|
34.3 years
STANDARD_DEVIATION 11.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Headache duration
Days (>24h)
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Headache duration
Hours (<24h)
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Headache duration
Weeks (>7d)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Self-medicated before ED presentation
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Visual Aura Present
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
International Classification of Headache Disorders
1.1 - Migraine without aura
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
International Classification of Headache Disorders
1.2 - Migraine with aura
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
International Classification of Headache Disorders
1.5.1 - Probably migraine without aura
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
International Classification of Headache Disorders
1.5.2 - probably migraine with aura
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Baseline categorical pain intensity
Severe
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Baseline categorical pain intensity
Severe-moderate
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline categorical pain intensity
Moderate
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Baseline categorical pain intensity
Mild
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline functional disability
No disruption
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline functional disability
Mildly impaired
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Baseline functional disability
Moderately impaired
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Baseline functional disability
Severely impaired
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Baseline NRS
|
8 scores on a scale
n=99 Participants
|
8.25 scores on a scale
n=107 Participants
|
8 scores on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutesNRS (National rating scale) pain score change from baseline following ketamine dose. Minimum score is 0, maximum score is 10, and higher scores mean worse pain.
Outcome measures
| Measure |
Placebo Control
n=18 Participants
Patients will receive an equivalent volume of normal saline intravenously.
Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Ketamine
n=16 Participants
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
|---|---|---|
|
Achievement of Pain Response After Ketamine Dose.
|
2.0 change in score on a scale
Interval 0.0 to 3.75
|
1.0 change in score on a scale
Interval 0.0 to 2.25
|
SECONDARY outcome
Timeframe: 30 minuteschange in baseline categorical pain score at 30 minutes (categorical pain intensity score from 0 to 3 where 0="no headache" and 3="severe headache")
Outcome measures
| Measure |
Placebo Control
n=18 Participants
Patients will receive an equivalent volume of normal saline intravenously.
Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Ketamine
n=16 Participants
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
|---|---|---|
|
Categorical Pain Score Change From Baseline
|
0.72 change in score on a scale
Interval 0.61 to 0.83
|
0.56 change in score on a scale
Interval 0.44 to 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 minuteschange in functional disability from baseline at 30 minutes (functional disability score from 0 to 3 where 0="no disruption of daily activities" and 3="performance of daily activities is severely impaired")
Outcome measures
| Measure |
Placebo Control
n=18 Participants
Patients will receive an equivalent volume of normal saline intravenously.
Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
Ketamine
n=16 Participants
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
|
|---|---|---|
|
Functional Disability Score Change From Baseline
|
0.39 change in score on a scale
Interval 0.3 to 0.48
|
0.44 change in score on a scale
Interval 0.32 to 0.56
|
Adverse Events
Placebo Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place