Status epilepticus and seizures are life-threatening emergencies, especially in children. While intravenous (IV) drugs can rapidly halt seizures, gaining IV access in a struggling patient can be difficult to impossible. An established alternative to IV in pediatrics is intraosseous (IO) infusion into the lower leg bone marrow. LifeQuest Medical has developed an IO auto-injector (the First-Med System) for emergency delivery of diazepam in pediatric seizures and epilepsy. A needle - drug cartridge - spring assembly generates sufficient force to puncture skin and bone, delivering a drug bolus into the tibial marrow in less than one second. The device is in testing for submission to the FDA to begin clinical trials. Questions to be answered are critical to commercialization of the device and to the understanding of IO drug delivery. The proposed study in chemically induced seizures in young pigs will determine the (1) relative bioavailability 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) effectiveness of the First-Med System to deliver drugs. Commercialization of this innovative device could reduce the morbidity and mortality in thousands of pediatric seizure patients.
