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

NCT02735343 | Terminated Phase 3 Results

• 1 other identifier: FWH20160057H
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.

  15 min, 30 min, 45 min, 60 min

Study Arms (2)

Standard treatment arm

ACTIVE COMPARATOR

compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously

Drug: Compazine

Research arm

EXPERIMENTAL

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

Drug: Ketamine

Interventions

Compazine DRUG

Compazine 10mg with diphenhydramine 25 mg IV

Also known as: prochlorperazine

Standard treatment arm

Ketamine DRUG

Ketamine 0.3 mg/kg along with ondansetron 4 mg IV

Research arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (2)

• 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.

  PMID: 29089172 DERIVED

• 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.

  PMID: 29033296 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Prochlorperazine; Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

This study was terminated early due to the study becoming unnecessary due to findings in another trial.

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.crawford.ctr@health.mil

7026533583

Study Officials

• Christopher Pitotti, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)