By Andy Dworkin
The Oregonian
PORTLAND, Ore. — Oregon paramedics will start testing a drug that could some day let people treat long, dangerous seizures even before an ambulance arrives.
If the test works, it could give a new anti-seizure tool not only to paramedics but also to people with seizure disorders and their families. But to test the drug, paramedics will have to inject it into people having seizures so severe they can’t agree to join the trial. A federal regulation allows these trials to go on without patient consent in rare circumstances where there’s no other way to test life-saving treatments.
These long seizures, called “status epilepticus,” can be deadly. The seizures strike an estimated 50,000 to 200,000 U.S. residents a year, killing about 20 percent of them. The attacks can last 30 minutes or more, destroying brain cells and making it hard to breathe.
Paramedics carry a drug, lorazepam, to treat these seizures. But it has to be given through a needle inserted into a vein. While IV drugs start to work fast, it can be tough to start an IV on someone having convulsive seizures. Another seizure drug, midazolam, can be injected into a muscle. That’s quicker but takes longer to act once in the body.
Both drugs “are quite standard” ways to stop seizures, said Dr. Robert Lowe, a professor of emergency medicine at Oregon Health & Science University, one of 17 U.S. sites involved in the test. But medics have never compared the two drugs head-to-head, the goal of this experiment.
“It’s so crucial to get the treatment in very, very quickly,” Lowe said. “The question is, is it better to get an IV in and give what is the best medicine to someone who (already) has an IV, or is it better to give the injection into the muscle that can be given quicker?”
Clackamas Fire District #1 is working with OHSU on the trial, training paramedics and equipping ambulances with special computerized boxes that will track when and where each drug is used.
Adults and children over about 28 pounds who are having prolonged seizures in Clackamas County will either get that midazolam injection or the traditional lorazepam IV. Which drug to give will be determined randomly, to allow comparison of the two treatments. Ambulances will carry the seizure patients to OHSU, Kaiser Sunnyside Medical Center, Portland Adventist Hospital, Providence Milwaukie Hospital Providence Portland Medical Center or Willamette Falls Hospital for more treatment.
The midazolam is packaged like the EpiPen self-injectors some people carry to fight life-threatening allergy attacks. If the midazolam injections prove to work as well or better than the IV drug, people with seizure disorders may some day carry their own injectors, so they or someone with them could give a shot to stop a status epilepticus. Right now, all families have are suppositories of the drug diazepam to try to insert in the rectum of someone having a seizure.
“Clearly, people would rather give an injection into a muscle,” Lowe said. “People with seizures, or people who have friends or family with seizures, were very enthusiastic about that” possibility.
OHSU principal investigator Dr. Craig Warden and other researchers discussed their plans for this trial with people who have seizures or are at risk of having one, such as stroke victims.
Such outreach is required by the government for trials in which patients don’t give their consent to take part. Lowe said the scientists did outreach to other community groups, including a Spanish-language meeting, before deciding to move ahead with the trial. Local and federal review boards also approved the trial, and an independent monitoring group will track the experiment as it proceeds, stepping in if it starts to look unsafe.
Anyone who doesn’t want to take part in the test can wear a bracelet that says “no study.” You can get one free by contacting OHSU at 503-494-9771. You also can request a bracelet or get more information on the Internet at www.ohsu.edu/emergency/rampart.
Portland paramedics and doctors have tested at least two other treatments under the federal consent waiver: Heart defibrillators in the community, which helped patients, and a concentrated saline solution for trauma victims, which didn’t help. Local doctors considered a third test of a blood substitute, but that trial was stopped for safety worries before Portland joined in.
About 700 people got the “no study” bracelets during the saline study, the most recent of those trials.
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