SAN FRANCISCO -- Injecting patients in the thigh with a drug-loaded syringe is a safe and effective way to stop a seizure in an emergency, according to results of a national study released Wednesday, a finding that could pave the way toward making such syringes as widely available as EpiPens used to treat severe allergic reactions.
The two-year study, published in the New England Journal of Medicine, concluded that a single stab from an auto-injector was more effective in stopping a prolonged seizure than the traditional method of inserting an intravenous line and delivering the drug directly into the bloodstream.
The results probably will change how such seizures, which can be life-threatening if they're not stopped right away, are treated by paramedics. But they could have more long-term repercussions if doctors start giving the auto-injectors to epileptic patients, some of whom have several severe seizures a year, to use at home, much as people with severe allergies carry epinephrine syringes with them.
"I don't think we're ready to hand these out at epilepsy clinics for people to take home right now," said Dr. J. Claude Hemphill, chief of neurology at San Francisco General Hospital, who led the San Francisco arm of the study. "But that may be a follow-up some folks want to do."
The U.S. Department of Defense also has taken special interest in the study, because auto-injectors would be much more convenient than IV drug treatment in a large-scale bioterrorism attack involving seizure-inducing nerve gas.
"The advantage is you can give it the auto-injection faster," said Dr. Walter Koroshetz, deputy director of the National Institute of Neurological Disorders and Stroke. "If you have 100 people simultaneously seizing, no way can you do all those IVs. But you could just run around and inject everybody for their seizures."
Seizures are caused by a disruption in the brain's electrical system, and in most cases they resolve themselves after a minute or so. Roughly 2 percent of Americans have epilepsy, a condition marked by chronic seizures.
Some seizures, known as status epilepticus or prolonged seizures, can last several minutes or longer, and they may require drugs to stop them. More than 50,000 people in the United States die from prolonged seizures every year, either from brain damage due to the seizure itself or from accidents related to passing out mid-attack.
The study, which was funded primarily by the National Institutes of Health, involved 79 hospitals nationwide, including several in the Bay Area. More than 4,000 paramedics were trained to participate in the study and 893 patients were treated.
A drug and a placebo
Every patient was given both the auto-injector shot, usually to the thigh, and an intravenous injection. But in half the cases the auto-injector was filled with a placebo, and in the other half the IV drug was a placebo. Neither patients nor paramedics knew which treatment was the placebo in any given case.
Researchers found that 73 percent of patients who were given the auto-injector drug had stopped seizing by the time they reached the emergency room; 63 percent of patients who got the IV drug were seizure-free.
Patients who were given the auto-injector drug were less likely than the IV group to be admitted to the hospital after their seizure.
"This auto-injection should be the new standard of care," said Dr. James Quinn, a professor of surgery and emergency medicine at Stanford who led the study there. "It's great when you can do a study and it's probably going to change how we do things."
Although two different drugs were used in the trial - midazolam for the auto-injector and lorazepam for the intravenous injection - researchers don't believe that the drugs made a difference in how effective the treatments were. Rather, they said, the auto-injectors are simply easier to use.
It's much simpler to give a single shot than to try to start an intravenous line on a patient who is actively convulsing, doctors and paramedics said. In the study, 42 patients did not receive the intravenous treatment because the paramedic couldn't start the IV, whereas only five patients didn't receive the auto-injector shot because the syringe malfunctioned.
"It takes time to set up an IV. You have to find a vein that's going to be good, you have to isolate the arm and hold it still, you have to clean the arm, you have to insert the needle," said Judy Klofstad, a paramedic with the San Francisco Fire Department who participated in the study. "If you're really good, it can take 2 1/2 minutes."
Paramedics took on average just 20 seconds to use the auto-injector, according to the study. "You just hold their thigh down, target it, and it can go right through their clothing, through jeans even," Klofstad said.
Doctors said that because the auto-injection drug causes heavy sedation and can lead to respiratory problems and low blood pressure, more research is needed before the syringes are handed out to patients.
But Tiffany Manning, who has epilepsy and suffers a prolonged seizure every two or three months, said she's excited about someday being able to carry around an auto-injector. Her doctor at the UCSF epilepsy clinic has prescribed an oral drug that her parents can give her when she has a seizure, but it can be time-consuming and difficult to measure out the proper dosage and make sure she swallows it, she said.
"And when I wake up I have a funny taste in my mouth," said Manning, 30. "My doctor doesn't prescribe it very often. You can overdose someone on it. ... I'd rather just have a shot in the leg."