The scenario unfolds almost every day in the United States. A crowd gathers at a playground, or perhaps on a soccer field. A child has fallen to the ground, gripped by a seizure.
Usually, the twitching and jerking stop within a few minutes. If they do not, the condition becomes status epilepticus, continuous unrelenting seizures that can lead to brain damage ? or even death ? if not treated.
An ambulance rushes the child to a nearby hospital emergency department. There, doctors do their best to administer life-saving treatment as quickly as possible. Before they can treat the patient, however, they must choose between one of two drugs commonly prescribed to treat the condition.
Yet no reliable information exists to determine which of the two drugs ? diazepam and lorazepam ? is more effective.
At a briefing at the National Institutes of Health, researchers today outlined plans for a large-scale national study to determine which of the two medications is the safest, most effective treatment for children with status epilepticus. The condition is life-threatening, and even with the best treatment, is fatal in 4 percent of cases. The study is the most comprehensive of its kind and 11 hospitals around the country will participate.
Lorazepam and diazepam are both administered to treat status epilepticus. Although both medications are regarded as standard treatment, no large-scale comparison has been conducted to determine which is the safest, most effective treatment. The Pediatric Seizure Study will compare the safety and effectiveness of the two medications in treating status epilepticus in children admitted to hospital emergency departments.
?Currently, the choice of treatment for status epilepticus depends upon the best judgment of the treating physician,? said Duane Alexander, M.D., Director of the NIH?s National Institute of Child Health and Human Development, which is sponsoring the study. ?The Pediatric Seizure Study seeks to provide the most definitive information possible on which medication offers the greater chance for successful treatment.?
Status epilepticus affects between 50,000 to 60,000 children and adults in the United States each year, explained the study?s principal investigator, James Chamberlain, M.D., Division Chief of Emergency Medicine at Children’s National Medical Center in Washington, D.C. He added that four to eight children per every 1,000 will experience status epilepticus before age 15. Status epilepticus may occur in patients with epilepsy or in patients without epilepsy who experience a seizure due to a high fever, low blood sugar, an infection of the central nervous system, or a head injury. Children who have no apparent risk factors may also develop status epilepticus.
Diazepam, more commonly known as Valium, has been approved by the U.S. Food and Drug Administration for use in adults and children. Lorazepam, marketed under the name Ativan, is only approved by the FDA to treat seizures in adult patients but is widely prescribed off label for children. Once a drug has been approved by the FDA for a particular use, physicians may use their best judgment to prescribe it for other uses, known as ?off label? uses, in other patients whom they believe might benefit.
?We want to hold these two medications to the highest standard and ensure that children are receiving the most appropriate medication for their condition,? Dr. Chamberlain said.