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

• Sponsor: University Medical Center of Southern Nevada (Other)
• Overall Status: Completed
• CT.gov ID: NCT02657031
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.1
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.

Condition or Disease	Intervention/Treatment	Phase
Headache	Drug: Prochlorperazine; Drug: Ketamine; Drug: Diphenhydramine; Drug: Ondansetron; Drug: Normal Saline	Phase 4

Detailed Description

After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read "randomized study medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-Blind Randomized Clinical Control TrialDouble-Blind Randomized Clinical Control Trial
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.
• Actual Study Start Date: Mar 17, 2016
• Actual Primary Completion Date: Mar 21, 2017
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Arm This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus	Drug: Prochlorperazine; prochlorperazine 10 mg IV; Other Names: Compazine ; Drug: Diphenhydramine; Diphenhydromine 25 mg IV; Other Names: Benadryl ; Drug: Normal Saline; Normal Saline 500 cc IV Bolus; Other Names: NS
Experimental: Study Arm This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.	Drug: Ketamine; Ketamine 0.3 mg/kg IV; Other Names: Ketalar ; Drug: Ondansetron; Ondansetron 4 mg IV; Other Names: Zofran ; Drug: Normal Saline; Normal Saline 500 cc IV Bolus; Other Names: NS

Outcome Measures

Primary Outcome Measures

1. Headache Following Intervention [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.

Secondary Outcome Measures

1. Anxiety [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.

2. Nausea [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.

3. The Number of Participants Experiencing Vomiting [0-60 minutes]

   Yes/No

4. The Number of Patients Experiencing Restlessness [0-60 minutes]

   Yes/No

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 to 65 years

• Temperature < 100.4° F

• Diastolic Blood Pressure <104 mm Hg

• Normal neurological exam and mormal mental status

Exclusion Criteria:

• Pregnant or breastfeeding.

• Meningeal signs are present

• Acute angle closure glaucoma is suspected.

• Head trauma within the previous two weeks

• Lumbar puncture within the previous two weeks

• Thunderclap onset of the headache

• Weight more than 150 kg or less than 40 kg.

• Known allergy to one of the study drugs.

• History of schizophrenia or bipolar disorder.

• History of intracranial hypertension.

• Is a prisoner

• Patient declined informed consent

• Non-English speaking patient.

• Attending provider excludes patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102

Sponsors and Collaborators

• University Medical Center of Southern Nevada

Investigators

• Principal Investigator: Joseph A Zitek, MD, Unviersity of Nevada School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 20, 2017

More Information

Publications

None provided.

• Responsible Party: University Medical Center of Southern Nevada
• ClinicalTrials.gov Identifier: NCT02657031
• Other Study ID Numbers: EM 2015.13
• First Posted: Jan 15, 2016
• Last Update Posted: Dec 11, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University Medical Center of Southern Nevada: Headache, Migraine
• Additional relevant MeSH terms: Headache; Diphenhydramine; Promethazine; Ketamine; Ondansetron; Prochlorperazine

Study Results

Participant Flow

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Period Title: Overall Study
STARTED	29	25
COMPLETED	28	23
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Control Arm	Study Arm	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	28	23	51
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	23 100%	51 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.4 (10.4)	32.3 (10.3)	34.9 (10.3)
Sex: Female, Male (Count of Participants)
Female	20 71.4%	19 82.6%	39 76.5%
Male	8 28.6%	4 17.4%	12 23.5%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	9 32.1%	7 30.4%	16 31.4%
Region of Enrollment (participants) [Number]
United States	28 100%	23 100%	51 100%
Visual Analog Scale (VAS) Pain Score, mm (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	78.3 (17.7)	77.8 (14.6)	78 (17)

Outcome Measures

1. Primary Outcome

Title	Headache Following Intervention
Description	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.
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Measure Participants	28	23
Mean (95% Confidence Interval) [mm]	63.5	43.5

2. Secondary Outcome

Title	Anxiety
Description	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.
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Measure Participants	28	23
Mean (Standard Deviation) [mm]	33.7 (32.5)	21.2 (40.5)

3. Secondary Outcome

Title	Nausea
Description	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.
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Measure Participants	28	23
Mean (Standard Deviation) [mm]	38.9 (34.8)	22.9 (37.5)

4. Secondary Outcome

Title	The Number of Participants Experiencing Vomiting
Description	Yes/No
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Measure Participants	28	23
Number [participants]	2 7.1%	3 13%

5. Secondary Outcome

Title	The Number of Patients Experiencing Restlessness
Description	Yes/No
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine	Ketamine and Ondansetron
Measure Participants	28	23
Number [participants]	3 10.7%	3 13%

Adverse Events

Time Frame	15 minutes
Arm/Group Title	Control Arm		Study Arm
Arm/Group Description	Prochlorperazine and Diphenhydramine		Ketamine and Ondansetron
All Cause Mortality
	Control Arm		Study Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/25 (0%)
Serious Adverse Events
	Control Arm		Study Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Study Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)		2/25 (8%)
Nervous system disorders
Dysphoria	1/29 (3.4%)	1	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.