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

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.

Intervention / Treatment

Double-Blind Randomized Clinical Control Trial
  • Prochlorperazine (DRUG)
    prochlorperazine 10 mg IV
  • Ketamine (DRUG)
    Ketamine 0.3 mg/kg IV
  • Diphenhydramine (DRUG)
    Diphenhydromine 25 mg IV
  • Ondansetron (DRUG)
    Ondansetron 4 mg IV
  • Normal saline (DRUG)
    Normal Saline 500 cc IV Bolus

Condition or Disease

  • Headache

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 54 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Mar 17, 2016 ACTUAL
    Primary Completion: Mar 21, 2017 ACTUAL
    Completion Date: Mar 21, 2017 ACTUAL
    Study First Posted: Jan 15, 2016 ESTIMATED
    Results First Posted: Dec 11, 2017 ACTUAL
    Last Updated: Dec 07, 2017

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    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).

    Participant Groups

    • This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus

    • This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • 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 Outcomes
    • 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.

    • 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.

    • Yes/No

    • Yes/No

    More Details

    NCT Number: NCT02657031
    Other IDs: EM 2015.13
    Study URL: https://clinicaltrials.gov/study/NCT02657031
    Last updated: Sep 29, 2023