Autoinjectors offer a way to treat prolonged seizures

HCMC EMS participates in NIH study that finds method safe, effective
for pre-hospital use

Delivering drugs into muscle using an autoinjector, akin to the EpiPen (used to treat serious allergic reactions), is faster and may be a more effective way to stop statusepilepticus (a prolonged seizure lasting longer than five minutes), according to a study sponsored by the National Institutes of Health (NIH). Status epilepticus is a potentially life-threatening emergency that causes 55,000 deaths each year.

Anticonvulsant drugs are typically delivered intravenously (IV) as a first-line treatment for status epilepticus; however, starting an IV in a patient experiencing seizures can pose a challenge for paramedics and waste precious time. Giving an intramuscular shot is easier, faster, and more reliable, especially in patients having convulsions. The researchers sought to determine whether an intramuscular injection, which quickly delivers anticonvulsant medicine into a patient’s thigh muscle, is as safe and effective as giving medicine directly into a vein. The study, which was carried out by paramedics, compared how well delivery by each method stopped patients’ seizures by the time the ambulance arrived at the emergency department. Several local hospitals participated in the 4-year study, but Hennepin Emergency Medical Service (EMS) was the only ambulance service in Minnesota to participate in the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART). RAMPART was conducted through the NINDS’ Neurological Emergencies Treatment Trials (NETT) network conducted locally by researchers at the University of Minnesota.

“Hennepin EMS was among the 33 EMS agencies (with  over 4300 paramedics) participating in the national RAMPART study,” explains emergency physician and one of the Principle Investigators, Michelle Biros, MD. “HCMC’s contribution was significant and only  possible because of the dedication of our paramedics and their desire to advance pre-hospital treatments of critically ill patients. As a researcher as well as an emergency care provider, I feel honored to work with these skilled and compassionate pre-hospital clinicians.”

Dr. Biros and the other investigators compared two medicines known to be effective in controlling seizures, midazolam and lorazepam. Both are benzodiazepines, a class of sedating anticonvulsant drugs. Midazolam was a candidate for injection because it is rapidly absorbed from muscle, but lorazepam must be given by IV. The study found that 73 percent of patients in the group receiving midazolam were seizure-free upon arrival at the hospital, compared to 63 percent of patients who received IV treatment withlorazepam. Patients treated with midazolam were also less likely to require hospitalization than those receiving IV lorazepam. Among those admitted, both groups had similarly low rates of recurrent seizures. The study appears in the Feb. 16, 2012 issue of The New England Journal of Medicine.

“The nature of the RAMPART study was ground-breaking,” reports Corey Sargent with the University of Minnesota, who was the local coordinator and EMS coordinator for RAMPART. “Paramedics used a research device that allowed them to document their work through a time-stamped voice recorder instead of the normal written documentation, which eased the burden of research on their clinical practice.”  This tool allowed paramedics to make quick decisions, indicate the time treatment began and the time the patient’s convulsions stopped, all without having to interrupt patient care to record data. The goal of the study was to control the seizures within 10 minutes without having to deliver a second dose of medicine. Prolonged status epilepticus can last for hours and sometimes is controlled only with general anesthesia.

“HCMC EMS completes one-eighth of all the ambulance calls in the State. This high volume, combined with their professionalism and attention to patients also made them the logical choice for pre-hospital involvement in a research study,” said Sargent.

The investigators said that while autoinjectors might someday be available for use by epilepsy patients and their family members, more research is required. Because of the strong sedative effect of midazolam, on-site medical supervision is now required for the safety of the patient.

RAMPART is the first randomized clinical trial to investigate whether intramuscular delivery of midazolam is as effective as IV lorazepam, the current standard of care therapy. The trial started in 2009 and completed enrollment in June, 2011. RAMPART involved more than 79 hospitals, 33 emergency medical services agencies, more than 4,000 paramedics and 893 patients ranging in age from several months old to 103. The network of investigators that designed and carried out the trial was established by NINDS to conduct clinical trials on a variety of acute conditions affecting the brain such as stroke and traumatic brain injury. NETT investigators are organized into a system of 17 major research hospitals each of which is linked to several community hospitals and other medical centers.

Brian Mahoney, MD is the medical director for Hennepin EMS and one of RAMPART’s Local Trial Principal Investigators. He looks forward to the applications that will result from this research, and is proud of the way HCMC EMS continues to lead the way in pre-hospital care. “Our paramedics do a great job with patients, they save lives, and through participation in  research like RAMPART, they are advancing the science of best practices in patient care.”

For more information about epilepsy, please visit www.ninds.nih.gov/epilepsy.

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NINDS (www.ninds.nih.gov) is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world.

About the National Institutes of Health (NIH):
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About the University of Minnesota Medical School
The University of Minnesota Medical School, with its two campuses in the Twin Cities and Duluth, is a leading educator of the next generation of physicians. Our graduates and the school’s 3,800 faculty physicians and scientists advance patient care, discover biomedical research breakthroughs with more than $180 million in sponsored research annually, and enhance health through world-class patient care for the state of Minnesota and beyond. Visit www.med.umn.edu to learn more.

About Hennepin County Medical Center and Hennepin EMS
Celebrating more than 20 years of being Minnesota’s first Level 1 Trauma Center,  Hennepin County Medical Center is a comprehensive academic medical center and public teaching hospital with the largest emergency department in the state. In addition to the 477-bed acute care hospital and primary care and specialty clinics located in downtown Minneapolis, Hennepin offers primary care clinics in Minneapolis and suburban Hennepin County. Hennepin County Medical Center is repeatedly recognized by U.S. News & World Report as one of “America’s Best Hospitals.”

For more than 100 years, HCMC has provided emergency medical services to Minneapolis and the surrounding area. The Hennepin EMS service area includes approximately 266 square miles and a population of over 500,000 residents, and responds to approximately 58,000 calls per year.