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

Headache Clinical Trial

Official title: The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Emergencies
• Headache

• NCT number: NCT02735343
• Study type: Interventional
• Source: Mike O'Callaghan Military Hospital
• Status: Terminated
• Phase: Phase 3
• Start date: August 2016
• Completion date: May 2017