Trial Outcomes & Findings for The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine (NCT NCT02735343)
NCT ID: NCT02735343
Last Updated: 2024-03-04
Results Overview
Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
5 participants
Primary outcome timeframe
15 min, 30 min, 45 min, 60 min
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
Standard Treatment Arm
compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
Compazine: Compazine 10mg with diphenhydramine 25 mg IV
|
Research Arm
Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Standard Treatment Arm
compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
Compazine: Compazine 10mg with diphenhydramine 25 mg IV
|
Research Arm
Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
|
|---|---|---|
|
Overall Study
screen fail
|
0
|
2
|
Baseline Characteristics
The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine
Baseline characteristics by cohort
| Measure |
Standard Treatment Arm
n=1 Participants
compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
Compazine: Compazine 10mg with diphenhydramine 25 mg IV
|
Research Arm
n=4 Participants
Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
|
Total
n=5 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
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 min, 30 min, 45 min, 60 minPopulation: This study was terminated early due to the study becoming unnecessary due to findings in another trial. Raw data were collected for the 3 subjects who completed the study (2 screen failed). Raw data is reported.
Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.
Outcome measures
| Measure |
Standard Treatment Arm
n=1 Participants
compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
Compazine: Compazine 10mg with diphenhydramine 25 mg IV
|
Research Arm
n=2 Participants
Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
|
|---|---|---|
|
Pain Score
Headache Score 0 minutes
|
39 score on a scale
Interval 39.0 to 39.0
|
74 score on a scale
Interval 68.0 to 80.0
|
|
Pain Score
headache score 15 minutes
|
18 score on a scale
Interval 18.0 to 18.0
|
16.5 score on a scale
Interval 16.0 to 17.0
|
|
Pain Score
headache score 30 minutes
|
8 score on a scale
Interval 8.0 to 8.0
|
19 score on a scale
1 subject lost to followup. The remaining subject scored 19.
|
|
Pain Score
headache score 45 minutes
|
—
|
10 score on a scale
1 subject lost to followup. The remaining subject scored 10.
|
|
Pain Score
headache score 60 minutes
|
—
|
13 score on a scale
1 subject lost to followup. The remaining subject scored 13.
|
Adverse Events
Standard Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Research Arm
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