An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin and Nurtec (Rimegepant) in Adult Patients Presenting to the ED With Acute Headache: Prospective, Randomized, Open-Label, Clinical Trial

2021-02-03-MMC

Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called "headache cocktail", which varies based on the physician, institution, and patient preferences.

2021-04-22

2022-09-30

2022-11-17

Completed

Early phase I

5

Inclusion Criteria: * Patients age 18 and older * Acute Headache * Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale. * Awake, alert, and oriented to person, place, and time Exclusion Criteria: * altered mental status, * allergy to aspirin, ketamine and rimegepant, * pregnancy and breastfeeding * unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg, pulse rate \<50 or \>150 beats/ min, and respiration rate \<10 or \>30 breaths/min) * inability to provide consent * consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen within 4 hours of arrival * active PUD * history of GI Hemorrhage * history of renal and hepatic insufficiency * past medical history of alcohol or drug abuse * schizophrenia * clinical findings concerning for acute intracranial process, acute infections process

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-01-31