This prospective, randomised, open-label trial (n=5) compared the analgesic efficacy and safety of a proprietary oral aspirin+ketamine formulation (AOK; ketamine 0.85 mg/kg + aspirin 324 mg) to Nurtec (rimegepant 75 mg ODT) in adult ED patients with 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.
Proprietary oral formulation of ketamine 0.85 mg/kg with aspirin 324 mg given as single oral dose in ED patients.
Co-formulated with aspirin 324 mg.
Rimegepant 75 mg orally disintegrating tablet (ODT) single dose comparator.
Nurtec (rimegepant) 75 mg ODT (active comparator encoded as placebo reference)