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

NCT ID: NCT02735343

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-05-31

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.

Detailed Description

Screening Visit:

• Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
• Record: Date of birth, age, phone number, gender, race, ethnicity, social security number, name of standard of care rescue medications (over-the-counter and prescription), current email address (to be used for scheduling only), height (in inches), weight (in pounds), history of traumatic brain injury, concussion, or any mild to severe head trauma, medication use. (research only)
• Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.
• Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).

Visit 1:

• Heart rate
• Blood pressure
• Headache severity via 100-mm VAS.
• Nausea severity via 100-mm VAS.
• Vomiting severity via 100-mm VAS.
• Anxiety severity via 100-mm VAS.
• Restlessness severity via 100-mm VAS.
• Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
• Subjects will be randomized by the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):

• Group 1: Standard treatment arm (prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV)
• Group 2: Research arm (Ketamine 0.3 mg/kg along with ondansetron 4 mg IV)

15 minutes post treatment:

• Heart rate
• Blood pressure
• Headache severity via 100-mm VAS.
• Nausea severity via 100-mm VAS.
• Vomiting severity via 100-mm VAS.
• Anxiety severity via 100-mm VAS.
• Restlessness severity via 100-mm VAS.

30 minutes post treatment:

• Heart rate
• Blood pressure
• Headache severity via 100-mm VAS.
• Nausea severity via 100-mm VAS.
• Vomiting severity via 100-mm VAS.
• Anxiety severity via 100-mm VAS.
• Restlessness severity via 100-mm VAS.

45 minutes post treatment:

• Heart rate
• Blood pressure
• Headache severity via 100-mm VAS.
• Nausea severity via 100-mm VAS.
• Vomiting severity via 100-mm VAS.
• Anxiety severity via 100-mm VAS.
• Restlessness severity via 100-mm VAS.

60 minutes post treatment:

• Heart rate
• Blood pressure
• Headache severity via 100-mm VAS.
• Nausea severity via 100-mm VAS.
• Vomiting severity via 100-mm VAS.
• Anxiety severity via 100-mm VAS.
• Restlessness severity via 100-mm VAS.

24-48 hours post treatment:

• Subjects will be contacted either in-person or via phone and the following information will be collected:

• Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain?"
• Subjects will be asked "On a scale of 0 to 10, how satisfied were you with you're the migraine pain management as part of this research study? (dissatisfied 0 - 10 very satisfied)
• Subjects will be alerted to what group they were randomized into.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard treatment arm

compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously

Group Type: ACTIVE_COMPARATOR

Compazine

Intervention Type: DRUG

Compazine 10mg with diphenhydramine 25 mg IV

Research arm

Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Ketamine 0.3 mg/kg along with ondansetron 4 mg IV

Interventions

Compazine

Compazine 10mg with diphenhydramine 25 mg IV

Intervention Type: DRUG

Ketamine

Ketamine 0.3 mg/kg along with ondansetron 4 mg IV

Intervention Type: DRUG

Other Intervention Names

prochlorperazine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Pitotti, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Medical Center

Locations

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Countries

United States

References

Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.

Reference Type: DERIVED

PMID: 29089172 (View on PubMed)

Zitek T, Gates M, Pitotti C, Bartlett A, Patel J, Rahbar A, Forred W, Sontgerath JS, Clark JM. A Comparison of Headache Treatment in the Emergency Department: Prochlorperazine Versus Ketamine. Ann Emerg Med. 2018 Mar;71(3):369-377.e1. doi: 10.1016/j.annemergmed.2017.08.063. Epub 2017 Oct 14.

Reference Type: DERIVED

PMID: 29033296 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FWH20160057H

Identifier Type: -

Identifier Source: org_study_id