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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

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
Headache Drug: Compazine Drug: Ketamine Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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 Name: 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




Primary Outcome Measures :
  1. Pain Score [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735343


Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Christopher Pitotti, MD Mike O'Callaghan Federal Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JillClark, Senior Research Associate/Research Manager, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02735343    
Other Study ID Numbers: FWH20160057H
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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.
Additional relevant MeSH terms:
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Emergencies
Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Prochlorperazine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents