An auto-injector delivering an anti-convulsant drug into the muscle of a patient's thigh is faster and may be a more effective way to stop epileptic seizures than delivering a drug intravenously, according to a study published in the Feb. 16 issue of the New England Journal of Medicine.
The study was conducted over three years at Oregon Health & Science University and 16 other major research hospitals across the nation, and involved more than 4,000 paramedics and 893 patients.
Epileptic seizures cause 55,000 deaths each year. The study's findings are important because it can be very difficult to administer a drug intravenously to a patient experiencing seizures; giving an intramuscular shot is easier, faster and more reliable — and thus could save lives.
“Getting treatment quickly to people suffering these seizures is vital to prevent potential brain injury,” said Craig Warden, M.D., M.P.H., an emergency physician at OHSU and the site principal investigator for the study. “And this study establishes that the auto-injector is a very quick way to deliver the medicine and it is safe and effective.”
The study — called the Rapid Anticonvulsant Medication Prior to Arrival Trial, or RAMPART — tested a device similar to an EpiPen, commonly used by people with severe allergies. Researchers wanted to determine whether administering a drug called midazolam through the EpiPen-like device was as safe and effective as giving another type of medicine — lorazepam — through an IV into the vein. Administering lorazepam through an IV is currently the standard of care for such seizures. The study, which was carried out by paramedics, compared how well each method and drug stopped patients’ seizures by the time the ambulance arrived at a hospital's emergency department.
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 with lorazepam. 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.
“Few other areas of medicine are as time-dependent as injury to the brain. In epilepsy, even a few minutes can be important. With every minute the seizure continues, it becomes harder to stop. RAMPART offers first responders an important treatment tool that will have a meaningful impact on the lives of many people with epilepsy,” said Robert Silbergleit, M.D., of the University of Michigan in Ann Arbor, first author of the NEJM paper.
The investigators said that while auto-injectors 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.
OHSU conducted the study in conjunction with Clackamas Fire District #1, and with several hospitals in the Portland region.
Because individuals having prolonged seizures may be unconscious or unable to consent to being part of a study, RAMPART was conducted under specific Food and Drug Administration guidelines that allow investigational treatment in certain life-threatening emergency situations without getting prior consent. The federal regulations that allow this exception from informed consent require representatives from the community be consulted and informed of the risks and benefits of the study.
The study was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health. Additional funding was provided by the NIH’s Countermeasures Against Chemical Threats program and the Biomedical Advanced Research and Development Authority. The Department of Defense’s Chemical Biological Medical Systems Joint Project Management Office provided the auto-injectors for the trial under a Memorandum of Agreement with NINDS.
For more information about epilepsy, please visit www.ninds.nih.gov/epilepsy.