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

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ClinicalTrials.gov Identifier: NCT02657031
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Medical Center of Southern Nevada

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

Condition or disease Intervention/treatment Phase
Headache Drug: Prochlorperazine Drug: Ketamine Drug: Diphenhydramine Drug: Ondansetron Drug: Normal Saline Phase 4

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind Randomized Clinical Control Trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.
Actual Study Start Date : March 17, 2016
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: Control Arm
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
prochlorperazine 10 mg IV
Other Name: Compazine

Drug: Diphenhydramine
Diphenhydromine 25 mg IV
Other Name: Benadryl

Drug: Normal Saline
Normal Saline 500 cc IV Bolus
Other Name: NS

Experimental: Study Arm
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
Ketamine 0.3 mg/kg IV
Other Name: Ketalar

Drug: Ondansetron
Ondansetron 4 mg IV
Other Name: Zofran

Drug: Normal Saline
Normal Saline 500 cc IV Bolus
Other Name: NS




Primary Outcome Measures :
  1. Headache Following Intervention [ Time Frame: 0-60 minutes ]
    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.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 0-60 minutes ]
    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.

  2. Nausea [ Time Frame: 0-60 minutes ]
    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.

  3. The Number of Participants Experiencing Vomiting [ Time Frame: 0-60 minutes ]
    Yes/No

  4. The Number of Patients Experiencing Restlessness [ Time Frame: 0-60 minutes ]
    Yes/No



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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

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

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): NCT02657031


Locations
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United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Sponsors and Collaborators
University Medical Center of Southern Nevada
Investigators
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Principal Investigator: Joseph A Zitek, MD Unviersity of Nevada School of Medicine
  Study Documents (Full-Text)

Documents provided by University Medical Center of Southern Nevada:

Publications of Results:

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Responsible Party: University Medical Center of Southern Nevada
ClinicalTrials.gov Identifier: NCT02657031     History of Changes
Other Study ID Numbers: EM 2015.13
First Posted: January 15, 2016    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was intended a multi-center (2 sites) study that would have shared redacted data with investigators from both sites, however, site #2 did not receive a data sharing agreement or IRB approval from their institution. So by default the study effectively became a single site study.

Keywords provided by University Medical Center of Southern Nevada:
Headache, Migraine

Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Diphenhydramine
Ondansetron
Prochlorperazine
Promethazine
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
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents