Intraosseous Injector for Diazepam in Seizures

Status epilepticus and seizures are life-threatening emergencies, especially in children. Whileintravenous (IV) drugs can rapidly halt seizures, gaining IV access in a struggling patient can be difficultto impossible. An established alternative to IV in pediatrics is intraosseous (IO) infusion into the lowerleg bone marrow. LifeQuest Medical has developed an IO auto-injector (the First-Med System) foremergency delivery of diazepam in pediatric seizures and epilepsy. A needle -- drug cartridge -- springassembly generates sufficient force to puncture skin and bone, delivering a drug bolus into the tibialmarrow in less than one second. The device is in testing for submission to the FDA to begin clinicaltrials. Questions to be answered are critical to commercialization of the device and to the understandingof IO drug delivery. The study in chemically induced seizures in young pigs will determine the (1) relativebioavailability and pharmacokinetics of diazepam by IV and IO routes in pediatric pigs in seizures, (2)volume to be injected into the tibia to produce an effect equivalent to an IV dose, and (3) effectivenessof the First-Med System to deliver drugs. Commercialization of this innovative device could reduce themorbidity and mortality in thousands of pediatric seizure patients.