Researchers to study seizure medications
under emergency conditions
Elizabeth Jones, M.D.
HOUSTON – (Dec. 9, 2008) – In a medical emergency, every second is vital, especially for patients suffering seizures, which could result in brain damage, organ injury or even death.
The University of Texas Health Science Center at Houston may soon launch a clinical trial to determine the best medication available for alleviating seizures before a patient even reaches the hospital. “Rapid Anticonvulsant Medication Prior to Arrival Trial,” or RAMPART, is a national study that will test the drugs Midazolam and Lorazepam, which are commonly used for treating seizures.
The study also will test the reliability of a new injector designed to administer drugs such as Midazolam into muscle tissue. Midazolam, which may work faster than Lorazepam, is approved by the U.S. Food and Drug Administration for sedation, but also has been used by doctors for treating seizures. If Midazolam proves to be more effective than Lorazepam, the muscle injector would be a quick way to give the drug while avoiding a needle stick risk to emergency personnel. Lorazepam requires an intravenous injection.
“If this study shows that Midazolam given in the muscle works as well as standard intravenous treatment for seizures, it will give all emergency personnel an easier and safer method for treating active seizures,” said Elizabeth Jones, M.D., assistant professor of emergency medicine at The University of Texas Medical School at Houston and principal investigator for the study in the Houston area.
In the study, patients will receive Lorazepam, Midazolam or a placebo. (The emergency personnel will not know which injections contain active medication.)
Because of the immediacy of the emergency, a patient who is seizing will be unable to give consent, and there may not be enough time to reach a family member for consent, which is normally a requirement. Instead, Jones’ research team will talk to community organizations, focus groups, churches and others about the study. If these community consultations reveal that the community does not support the research, then the study will be modified or not conducted.
If the community is in support of the study, an implied consent would be assumed. People would be able to decline participation in the study before it begins by sending an e-mail to Misty.Ottman@uth.tmc.edu. They would be issued a bracelet that reads “RAMPART declined,” and it would need to be worn at all times during the study. The study is expected to last 3 years.
RAMPART is sponsored by the Neurological Emergencies Treatment Trials Network (NETT), created by the National Institutes of Health (NIH). NETT was created to conduct trials that could help lessen the severity of acute injuries and illnesses that affect the brain, spinal cord and peripheral nervous system. It provides the basis for studies that involve rapid intervention, both in the field and in emergency department situations.
For information about RAMPART, go to www.nett.umich.edu and click on “Community,” or call (734) 232-2142.