This prospective, randomised, open-label trial (n=5) compared the analgesic efficacy and safety of a proprietary formulation of orally administered aspirin and ketamine (AOK) to Nurtec (Rimegepant) in adult patients presenting to the Emergency Department (ED) with acute headache.
Patients aged 18 and older with an initial pain score of 5 or more on a standard 11-point numeric rating scale were included. The trial, led by Antonios Likourezos, aimed to determine if AOK provides similar analgesia to Nurtec at 60 minutes post-medication administration.
The study began in April 2021 and concluded in November 2022 at Maimonides Medical Center, Brooklyn, New York. Patients were randomised into two groups: Group I received AOK, while Group II received Nurtec.
Primary outcomes included a comparative reduction in pain scores at 60 minutes post-administration. Secondary outcomes comprised the need for rescue analgesia, rates of adverse effects, and change in pain score up to 120 minutes.
Data collection involved patient assessment, vital signs monitoring, and adverse effects evaluation.
Trial Details
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.NCT Number NCT04860713