Drug delivery 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 status epilepticus, a prolonged seizure lasting longer than five minutes, according to a study.
Status epilepticus causes 55,000 deaths each year. Anticonvulsant drugs are typically delivered intravenously as a first-line treatment.
Starting an IV on a patient experiencing seizures can pose a challenge and waste precious time, according to a news release. 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 ED. The investigators compared two medicines known to be effective in controlling seizures, midazolam and lorazepam. Both are benzodiazapines, a class of sedating anticonvulsant drugs. Midazolam was a candidate for injection because it is rapidly absorbed from muscle, while lorazepam must be given by IV.
The study found that 73% of patients in the group receiving midazolam were seizure-free upon arrival at the hospital, compared to 63% 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.
“Patients with status epilepticus can suffer severe consequences if seizures are not stopped quickly,” said Walter Koroshetz, MD, deputy director of the National Institute of Neurological Disordders and Stroke, part of the National Institutes of Health, which funded the study.
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.
The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) study 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 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.
“Few other areas of medicine are as time-dependent as injury to the brain,” said Robert Silbegleit, MD, of the University of Michigan in Ann Arbor and first author of the paper. “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.”
The study appears in the Feb. 16 issue of the New England Journal of Medicine. To read a study summary and access the study via subscription or purchase, visit http://bit.ly/zfjw2B.