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

FWH20160057H

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.

2016-08-01

2017-05-01

2017-05-01

Terminated

Early phase I

5

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-03-04