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

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

Detailed Description
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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).

Official Title
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The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.

Conditions
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Headache

Intervention / Treatment
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* Drug: Prochlorperazine
* Drug: Ketamine
* Drug: Diphenhydramine
* Drug: Ondansetron
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind Randomized Clinical Control Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>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<br>* prochlorperazine 10 mg IV<br>* Other names: Compazine;Drug: Diphenhydramine<br>* Diphenhydromine 25 mg IV<br>* Other names: Benadryl;Drug: Normal Saline<br>* Normal Saline 500 cc IV Bolus<br>* Other names: NS;|
| Experimental: Study Arm<br>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<br>* Ketamine 0.3 mg/kg IV<br>* Other names: Ketalar;Drug: Ondansetron<br>* Ondansetron 4 mg IV<br>* Other names: Zofran;Drug: Normal Saline<br>* Normal Saline 500 cc IV Bolus<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Following Intervention | 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. | 0-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | 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. | 0-60 minutes | 
| Nausea | 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. | 0-60 minutes | 
| The Number of Participants Experiencing Vomiting | Yes/No | 0-60 minutes | 
| The Number of Patients Experiencing Restlessness | Yes/No | 0-60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Migraine