Emergency Auto Injector Anti-Seizure Treatments to be Studied
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A new University of Kentucky study may help give paramedics a different option for treating patients' seizures and preventing them from injuring themselves before they receive more treatment at a hospital.

The clinical trial will determine whether it is as effective to use an auto injector to deliver anti-seizure medications to patients intramuscularly (IM) as it is to treat seizing patients by intravenous injection (IV), the current protocol used by Emergency Medical Services (EMS).

“We believe we have a better method, which is an auto injector, to give medication as fast or faster than a paramedic can get an IV started,”  said Dr. Roger Humphries, chairman of the Department of Emergency Medicine at UK and principal investigator of the study. "IVs can be hard to start quickly in patients who are seizing violently, especially in the small veins of children."

An auto injector is a spring-loaded syringe that rapidly delivers a single unit dose of a drug. A similar device, the EpiPen, is used to administer epinephrine, a drug that is effective in treating severe asthma attacks.

The UK research team was selected along with 16 other prominent research institutions across the nation to conduct the emergency medicine trial known as RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) within the Neurological Emergencies Treatment Trials (NETT) Network. The network, formed by the National Institutes of Health, conducts large, simple clinical trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord, and peripheral nervous system.

“Prolonged seizures are dangerous and may be life threatening," said Dr. Creed Pettigrew, co-investigator and professor of neurology. "It’s estimated that as many as 200,000 episodes of prolonged seizures requiring medical intervention occur each year, resulting in as many as 55,000 deaths.”

What makes this trial unique from most others is the FDA federal regulation called “exception from informed consent.” Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board review and approval. They give the researcher the ability to enroll patients into the study when they cannot speak for themselves because of their life-threatening injury or illness.

Another innovative tool that will be used during the process is called a "study box" which contains a global positioning system (GPS) and a voice data recorder. The box will also contain the drugs being used in the study. When EMTs are working on a seizing patient, the GPS unit will record the time and location of the scene. The GPS is programmed with the hospital coordinates and using the voice recorder, the paramedics will record when the IV is started or when the shot is given. They will also record when the patient stops seizing. 

"It is so difficult to do emergency research when you have a very short window of opportunity and the urgent need is to treat the patient rather than gather data for a study," said Humphries. "The GPS and data voice recorder greatly improve the ability to collect study data while rendering treatment. This study could easily become a model for future  studies done on ambulances."

Exception from informed consent requires that the community receive education about the study and have the opportunity to provide feedback for the university's institutional review board, which is responsible for evaluating and approving research studies.The reason emergency research like this is allowed, Humphries and study coordinator Linda Dechtenberg explain, is because patients may be unable to provide consent, or the time it takes to explain the study could delay life-saving treatment.

“You are not going to be able to consent if you are seizing,” says Dechtenberg, also a registered nurse. She added that persons wishing not to be included can request an opt-out bracelet that indicates to paramedics the patient declines to be part of this study.

According to Pettigrew, people with a history of prolonged seizures will make up the majority of study subjects, although someone with no history of seizures, experiencing a first-time seizure, could become part of the study as well.

“Patients with prolonged seizures will be treated by paramedics with the same type of medications that we are using in the study," said Humphries. "The principal issue in the trial is the method of delivering that medication. If we can demonstrate that the auto injector method is as effective as starting an IV and delivering medication by that method, then we will be able to offer a wonderful new method to routinely treat prolonged seizures.”

The UK research team held focus group meetings in Lexington to discuss the study, including Epilepsy Support Group meetings, educational seminars and other events conducted by the Kentuckiana Chapter of the Epilepsy Foundation in addition to meeting with community primary care physicians.