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

Study Overview
=================
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.

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

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Drug: Compazine
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment arm<br>compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously | Drug: Compazine<br>* Compazine 10mg with diphenhydramine 25 mg IV<br>* Other names: prochlorperazine;|
| Experimental: Research arm<br>Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously | Drug: Ketamine<br>* Ketamine 0.3 mg/kg along with ondansetron 4 mg IV<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score |  | 60 minutes |