UK Studies Shot for Seizures

Lexingtonians who are rushed to the emergency room because of a seizure soon might be part of a clinical trial.

The trial, which the University of Kentucky is leading locally, will examine whether anti-seizure medication can be delivered faster with an auto-injector -- a spring-loaded, single-dose syringe -- than intravenously.

"IVs can be hard to start quickly in patients who are seizing violently," said Dr. Roger Humphries, chairman of the Department of Emergency Medicine at UK.

Humphries says the study will show which treatment is more effective.

UK is one of 17 medical institutions nationwide participating in the study, funded by the National Institutes of Health.

Normally, clinical trials require participants to give consent. However, in this case, study participants won't be able to consent; they'll be in the midst of a seizure.

The trial is being operated under a Food and Drug Administration exception that requires UK to educate residents about the study. In addition, the medical center is offering opt-out bracelets for those who do not want to participate.

The trial is expected to start in March.

Lexington ambulances will carry small plastic boxes with medication for the study and a voice data recorder. When the box is opened, it will record the time and location, and paramedics will be able to record information orally rather than writing it down.

All participants, who will include children who weigh 28.6 pounds or more, will be given a shot in the upper thigh and an IV. One will contain study medication; the other will contain saline.

Study participants who are given medication by IV will receive lorazepam. The medication usually is given by IV.

Those who receive medication from the shot will get midazolam, which is usually given by shot. Both medications, which are in the Valium family, already are used to stop seizures, Humphries said.

Medication given by IV is absorbed by the body more quickly than medication injected into a muscle, he said.

"But it might take 15 or 20 minutes in some patients to get an IV," Humphries said.

Children can be particularly difficult.

Two years ago, UK participated in a controversial, no-consent study that involved a blood substitute, PolyHeme, for trauma patients. This trial is different, Humphries said, because the drugs involved already have FDA approval and have been used for many years to treat seizures.

"These are two very well-established drugs," he said.