A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone in Adult Patients Presenting to the ED With Acute Musculoskeletal Pain: Prospective, Randomized, Open-Label, Clinical Trial.

2021-02-02-MMC

Acute Pain is one of the most frequent chief complaints and the main reason for visiting the Emergency Department (ED). The acute pain in the ED is largely prevalent across the country with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a variety of acute painful syndromes. There is a lack of good options for pain control in such settings.

2021-04-22

2021-11-30

2021-12-31

Completed

Early phase I

60

Inclusion Criteria: * Patients age 18 and older * acute musculoskeletal pain * 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 and ketamine, * pregnant * 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 * active PUD * history of GI Hemorrhage * history of renal and hepatic insufficiency * past medical history of alcohol or drug abuse * schizophrenia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-04-07