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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

Tracking Information
First Submitted Date  ICMJE January 13, 2016
First Posted Date  ICMJE January 15, 2016
Results First Submitted Date  ICMJE October 25, 2017
Results First Posted Date  ICMJE December 11, 2017
Last Update Posted Date December 11, 2017
Actual Study Start Date  ICMJE March 17, 2016
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
Headache [ Time Frame: 0-60 minutes ]
100 mm VAS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • 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.
  • 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.
  • The Number of Participants Experiencing Vomiting [ Time Frame: 0-60 minutes ]
    Yes/No
  • The Number of Patients Experiencing Restlessness [ Time Frame: 0-60 minutes ]
    Yes/No
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Anxiety [ Time Frame: 0-60 minutes ]
    100 mm VAS
  • Nausea [ Time Frame: 0-60 minutes ]
    100 mm VAS
  • Vomiting [ Time Frame: 0-60 minutes ]
    Yes/No
  • Restlessness [ Time Frame: 0-60 minutes ]
    Yes/No
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
Official Title  ICMJE The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-Blind Randomized Clinical Control Trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • Drug: Prochlorperazine
    prochlorperazine 10 mg IV
    Other Name: Compazine
  • Drug: Ketamine
    Ketamine 0.3 mg/kg IV
    Other Name: Ketalar
  • Drug: Diphenhydramine
    Diphenhydromine 25 mg IV
    Other Name: Benadryl
  • Drug: Ondansetron
    Ondansetron 4 mg IV
    Other Name: Zofran
  • Drug: Normal Saline
    Normal Saline 500 cc IV Bolus
    Other Name: NS
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Diphenhydramine
    • Drug: Normal Saline
  • 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.
    Interventions:
    • Drug: Ketamine
    • Drug: Ondansetron
    • Drug: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
70
Actual Study Completion Date  ICMJE March 21, 2017
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657031
Other Study ID Numbers  ICMJE EM 2015.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party University Medical Center of Southern Nevada
Study Sponsor  ICMJE University Medical Center of Southern Nevada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph A Zitek, MD Unviersity of Nevada School of Medicine
PRS Account University Medical Center of Southern Nevada
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP