An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Prospective, randomised, open-label equivalence trial in ED patients (n=5) comparing AOK (ketamine 0.85 mg/kg plus aspirin 324 mg) to rimegepant 75 mg ODT; primary outcome is change in pain NRS at 60 minutes.

Secondary outcomes include need for rescue analgesia and rates of adverse effects up to 120 minutes; dissociative and agitation scales (SERSDA, RASS) and vital signs are used for safety monitoring.