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

Sponsor
Mike O'Callaghan Military Hospital (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT02735343
Collaborator
(none)
5
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard treatment arm

compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously

Drug: Compazine
Compazine 10mg with diphenhydramine 25 mg IV
Other Names:
  • prochlorperazine

    		•
    Experimental: Research arm

    Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously

    Drug: Ketamine
    Ketamine 0.3 mg/kg along with ondansetron 4 mg IV

    Outcome Measures

    Primary Outcome Measures

    1. Pain Score [60 minutes]

    Eligibility Criteria

    Criteria

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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mike O'Callaghan Federal Medical Center Nellis Air Force Base Nevada United States 89191

    Sponsors and Collaborators

    • Mike O'Callaghan Military Hospital

    Investigators

    • Principal Investigator: Christopher Pitotti, MD, Mike O'Callaghan Federal Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JillClark, Senior Research Associate/Research Manager, Mike O'Callaghan Military Hospital
    ClinicalTrials.gov Identifier:
    NCT02735343
    Other Study ID Numbers:
    • FWH20160057H
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    Jun 2, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Emergencies
    Headache
    Ketamine
    Prochlorperazine

    Study Results

    No Results Posted as of Jun 2, 2017