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

December 7, 2017 updated by: University Medical Center of Southern Nevada

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Compazine
Drug: Diphenhydramine
Diphenhydromine 25 mg IV
Other Names:
  • Benadryl
Drug: Normal Saline
Normal Saline 500 cc IV Bolus
Other Names:
  • 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: Normal Saline
Normal Saline 500 cc IV Bolus
Other Names:
  • NS
Drug: Ketamine
Ketamine 0.3 mg/kg IV
Other Names:
  • Ketalar
Drug: Ondansetron
Ondansetron 4 mg IV
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center of Southern Nevada

Investigators

  • Principal Investigator: Joseph A Zitek, MD, Unviersity of Nevada School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2016

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM 2015.13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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