This is a seizure study that is evaluating two commonly used seizure medications - they are Versed (housed in an autoinjector, so used IM) and Ativan (IV use). There are approximately 50 EMS departments across the USA that will be enrolling patients. The goal is to see if Versed IM is as safe and as effective in stopping tonic/clonic seizures as Ativan.
Research showed that it doesn't get absorbed as rapidly Intranasal as Intramuscular. IM Versed is a "off label" use and not currently approved by the FDA. Ativan is the "gold standard" in hospital but has problems for out of hospital use due to short expiration dates if not refrigerated.
The goal is to assess if IV Ativan and IM Versed (placed in autoinjectors) are comparable in several ways such as safety, stopping the seizure and preventing recurrence of seizures.
Auto Injectors just seem like an expensive way to go. Could you point me in the direction of the research about intranasal versed. Also, why not just give the versed IM with a regular syringe and needle? Are they trying to validate the autoinjector for home or BLS use?
The research project also includes evaluating the use of the auto-injector. There are many potential uses for an auto-injector and medications. The current uses are the Epi Pen and Epi-Pen Jr. Also the Mark I and DuoDotes for WMD. Currently most states stockpile valium for WMD seizures but there is also a study of Valium in auto-injectors and the RAMPART study of Versed in auto-injectors.
Rob Theriault said:
hmmm...why IM? Why not intranasal midazolam - more rapid absorption and onset of action. It's arguably a safer route for a patient in a tonic-clinic state. :) Rob Theriault Paramedic Tutor
Our enrollment is up to 94 now! the total patients that will be enrolled across the USA is 800. I was at New York Presbyterian EMS and Austin/TC EMS this month. Great trips and I got to meet a lot of great EMS folks.