Intramuscular midazolam versus intravenous lorazepam in the pre-hospital treatment of status epilepticus (the RAMPART trial)

Principal Investigator – Claude Hemphill, MD, Department of Neurology, San Francisco General Hospital

Co-Investigator – Karl Sporer, MD, Medical Director SFFD Emergency Medical Services Division

Emergency Medicine Physicians and Neurologists at San Francisco General Hospital and throughout San Francisco are conducting a research study to determine the best treatment for a prolonged seizure called status epilepticus.

A prolonged seizure is a sudden and prolonged disruption of the brain’s normal electrical activity.  It can often cause unconsciousness and jerking and twitching activity.  It is a MEDICAL EMERGENCY.

Currently, paramedics usually treat prolonged seizures with an intravenous (IV) sedative.  It is thought that a similar medication given as an injection in the muscle may be as or more effective, as well as safer and easier to administer.  “Both medications are already approved by the FDA for use in seizure control in adults. Midazolam is not approved by the FDA for use in children, but it has been widely used and its efficacy has been documented in the pediatric medical literature.”

The GOAL of this study is to find out if giving one medication (midazolam) in the muscle works as well as giving another medication (lorazapam) in the vein.

THE PROBLEM:  1) Eligible patients are unconscious and are therefore unable to give consent (permission) to participate in the study. 2) The study medication must be given very rapidly as this condition is a medical emergency.

THE SOLUTION:  “Exception from Informed Consent” – this means that due to their illness, patients will not be able to give their permission or consent before being enrolled in the study. Because this involves a medical emergency, there is also not time to explain the study and obtain consent before study treatment. In order to conduct a study using “Exception from Informed Consent”, the State of California and the Federal Government regulations require that we discuss the study with the community to allow groups and individuals to ask questions and to determine if there is community support. Patients and/or their families will be notified and informed about the study after their arrival to the hospital by ambulance.

For more information about this study, contact Michele Meeker, RN, BSN at meekerm@ neurosurg.ucsf.edu or by phone at 206-3220.  Please see the UCSF Committee on Human Research (CHR) web page at www.ucsf.edu/ora/chr  for information on protection of human subjects.  This site provides links to the FDA web site as well.  You can also call the CHR at 476-1814.

This study is being funded by the National Institutes of Health through the Neurological Emergencies Treatment Trials Network (NETT)