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

February 28, 2024 updated by: Mike O'Callaghan Military Hospital

The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Federal Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 15 min, 30 min, 45 min, 60 min
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.
15 min, 30 min, 45 min, 60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20160057H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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