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The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine (Check)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735343
Recruitment Status : Terminated (only recruited 5 patients at this location)
First Posted : April 12, 2016
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
JillClark, Mike O'Callaghan Military Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date June 2, 2017
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
Pain Score [ Time Frame: 60 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine
Official Title  ICMJE The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial
Brief Summary Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.
Detailed Description

Screening Visit:

  • Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
  • Record: Date of birth, age, phone number, gender, race, ethnicity, social security number, name of standard of care rescue medications (over-the-counter and prescription), current email address (to be used for scheduling only), height (in inches), weight (in pounds), history of traumatic brain injury, concussion, or any mild to severe head trauma, medication use. (research only)
  • Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.
  • Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).

Visit 1:

  • Heart rate
  • Blood pressure
  • Headache severity via 100-mm VAS.
  • Nausea severity via 100-mm VAS.
  • Vomiting severity via 100-mm VAS.
  • Anxiety severity via 100-mm VAS.
  • Restlessness severity via 100-mm VAS.
  • Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
  • Subjects will be randomized by the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):

    • Group 1: Standard treatment arm (prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV)
    • Group 2: Research arm (Ketamine 0.3 mg/kg along with ondansetron 4 mg IV)

      15 minutes post treatment:

  • Heart rate
  • Blood pressure
  • Headache severity via 100-mm VAS.
  • Nausea severity via 100-mm VAS.
  • Vomiting severity via 100-mm VAS.
  • Anxiety severity via 100-mm VAS.
  • Restlessness severity via 100-mm VAS.

    30 minutes post treatment:

  • Heart rate
  • Blood pressure
  • Headache severity via 100-mm VAS.
  • Nausea severity via 100-mm VAS.
  • Vomiting severity via 100-mm VAS.
  • Anxiety severity via 100-mm VAS.
  • Restlessness severity via 100-mm VAS.

    45 minutes post treatment:

  • Heart rate
  • Blood pressure
  • Headache severity via 100-mm VAS.
  • Nausea severity via 100-mm VAS.
  • Vomiting severity via 100-mm VAS.
  • Anxiety severity via 100-mm VAS.
  • Restlessness severity via 100-mm VAS.

    60 minutes post treatment:

  • Heart rate
  • Blood pressure
  • Headache severity via 100-mm VAS.
  • Nausea severity via 100-mm VAS.
  • Vomiting severity via 100-mm VAS.
  • Anxiety severity via 100-mm VAS.
  • Restlessness severity via 100-mm VAS.

24-48 hours post treatment:

  • Subjects will be contacted either in-person or via phone and the following information will be collected:

    • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain?"
    • Subjects will be asked "On a scale of 0 to 10, how satisfied were you with you're the migraine pain management as part of this research study? (dissatisfied 0 - 10 very satisfied)
  • Subjects will be alerted to what group they were randomized into.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • Drug: Compazine
    Compazine 10mg with diphenhydramine 25 mg IV
    Other Name: prochlorperazine
  • Drug: Ketamine
    Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
Study Arms  ICMJE
  • Active Comparator: Standard treatment arm
    compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
    Intervention: Drug: Compazine
  • Experimental: Research arm
    Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
    Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
70
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria

  • Age 18 to 65 years who present to the ED with complaint of a headache
  • Temperature less than 100.4 F
  • Diastolic blood pressure less than 104 mm Hg
  • Normal neurologic exam and normal 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 (rapid) onset of the headache
  • Weight more than 150 kg or less than 40 kg
  • Known allergy to diphenhydramine
  • Known allergy to ondansetron. (Zofran)
  • Known allergy to Compazine
  • Known allergy to Ketamine
  • 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
  • Elderly patients with dementia
  • Patients with severe headaches that diminish their decision making capability will not be able to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735343
Other Study ID Numbers  ICMJE FWH20160057H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with University Medical Center of Southern Nevada via a Cooperative Research and Development Agreement. They are conducing the same study under a different IRB.
Responsible Party JillClark, Mike O'Callaghan Military Hospital
Study Sponsor  ICMJE Mike O'Callaghan Military Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Pitotti, MD Mike O'Callaghan Federal Medical Center
PRS Account Mike O'Callaghan Military Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP