Midazolam for Treatment of Status Epilepticus

Analyzing data from completed studies with midazolam, a fast-acting medication for treatment of seizures, to support labeling for use in children.

Midazolam is a benzodiazepine that has been previously approved for sedation, anxiolysis, amnesia, and anesthesia in children and adults. This analysis will provide supplemental data to support the change of the current midazolam prescription labeling to include the treatment of seizures in children ages 2 years and older.

Summary

Status epilepticus is a common neurological and medical emergency affecting approximately 120,000 individuals in the United States each year and resulting in 55,000 deaths. Of these deaths, 8% are children. If status epilepticus is not treated promptly, the seizures may result in permanent brain damage or death.

The two most common U.S. Food and Drug Administration-approved anti-convulsants for the treatment of seizures (diazepam and lorazepam) are absorbed more slowly than midazolam when given intramuscularly (midazolam takes 5-7 minutes versus 25-30 minutes for diazepam to reach therapeutic levels). Midazolam has become a favorite of first responders who care for children as it has a very favorable safety and efficacy profile and is easy to administer to a child.

The goal of this study is to extend the label of midazolam to include the treatment of seizures in children by analyzing and reviewing data from a number of completed studies.

OVERVIEW

Status:
Analysis ongoing

Principal Investigator:
P. Brian Smith, MD, MPH, MHS
Duke Health, Durham, NC

NEWS