Trial Outcomes & Findings for The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine (NCT NCT02657031)

NCT ID: NCT02657031

Last Updated: 2017-12-11

Results Overview

Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: 0-60 minutes
• Results posted on: 2017-12-11

Participant Flow

Participant milestones

Measure	Control Arm Prochlorperazine and Diphenhydramine	Study Arm Ketamine and Ondansetron
Overall Study STARTED	29	25
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Control Arm Prochlorperazine and Diphenhydramine	Study Arm Ketamine and Ondansetron
Overall Study Adverse Event	1	2

Baseline Characteristics

The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine

Baseline characteristics by cohort

Measure	Control Arm n=28 Participants This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus Prochlorperazine: prochlorperazine 10 mg IV Diphenhydromine: Diphenhydromine 25 mg IV Normal Saline: Normal Saline 500 cc IV Bolus	Study Arm n=23 Participants This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Sailing 500 cc bolus. Ketamine: Ketamine 0.3 mg/kg IV Ondansetron: Ondansetron 4 mg IV Normal Saline: Normal Saline 500 cc IV Bolus	Total n=51 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	28 Participants n=5 Participants	23 Participants n=7 Participants	51 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	37.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	32.3 years STANDARD_DEVIATION 10.3 • n=7 Participants	34.9 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	23 participants n=7 Participants	51 participants n=5 Participants
Visual Analog Scale (VAS) Pain Score, mm	78.3 mm STANDARD_DEVIATION 17.7 • n=5 Participants	77.8 mm STANDARD_DEVIATION 14.6 • n=7 Participants	78 mm STANDARD_DEVIATION 17 • n=5 Participants

PRIMARY outcome

Timeframe: 0-60 minutes

Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.

Outcome measures

Measure	Control Arm n=28 Participants Prochlorperazine and Diphenhydramine	Study Arm n=23 Participants Ketamine and Ondansetron
Headache Following Intervention	63.5 mm Interval 52.7 to 74.3	43.5 mm Interval 30.2 to 56.8

SECONDARY outcome

Timeframe: 0-60 minutes

Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.

Outcome measures

Measure	Control Arm n=28 Participants Prochlorperazine and Diphenhydramine	Study Arm n=23 Participants Ketamine and Ondansetron
Anxiety	33.7 mm Standard Deviation 32.5	21.2 mm Standard Deviation 40.5

SECONDARY outcome

Timeframe: 0-60 minutes

Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.

Outcome measures

Measure	Control Arm n=28 Participants Prochlorperazine and Diphenhydramine	Study Arm n=23 Participants Ketamine and Ondansetron
Nausea	38.9 mm Standard Deviation 34.8	22.9 mm Standard Deviation 37.5

SECONDARY outcome

Timeframe: 0-60 minutes

Yes/No

Outcome measures

Measure	Control Arm n=28 Participants Prochlorperazine and Diphenhydramine	Study Arm n=23 Participants Ketamine and Ondansetron
The Number of Participants Experiencing Vomiting	2 participants	3 participants

SECONDARY outcome

Timeframe: 0-60 minutes

Yes/No

Outcome measures

Measure	Control Arm n=28 Participants Prochlorperazine and Diphenhydramine	Study Arm n=23 Participants Ketamine and Ondansetron
The Number of Patients Experiencing Restlessness	3 participants	3 participants

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Arm n=29 participants at risk Prochlorperazine and Diphenhydramine	Study Arm n=25 participants at risk Ketamine and Ondansetron
Nervous system disorders Dysphoria	3.4% 1/29 • Number of events 1 • 15 minutes	8.0% 2/25 • Number of events 2 • 15 minutes

Additional Information

Dr. Tony Zitek

University Medical Center Emergency Department

Phone: 7022247124

Email: zitek10@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place