( .S. Food and Drug Administration for us...)Pediatric Seizure Study Underway in US to Decide Between Diazepam and Lorazepam,Health

.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.

To conduct the study, researchers at the 11 participating hospitals will randomly assign children who are in status epilepticus to be treated with either lorazepam or diazepam, explained the studys co-principal investigator, Jill Baren of the Division of Emergency Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, PA. Usually, the choice of which drug to prescribe would rest with the treating physician. During the study, however, the medication will be assigned randomly by a computer, to eliminate any potential human bias in assigning the medication. A roughly equal number of the children will receive each medication.

Dr. Baren added that status epilepticus must be treated within 5 minutes or less of a childs arrival in an emergency department. Without prompt treatment, brain injury or death could result. This means that it will not be possible to obtain permission from a childs parent or guardian before enrolling the child in the study.

Normally, researchers first ask the parent or guardian for permission to enroll a child in a study, explain the details and procedures of the study, its potential risks and benefits, and alternatives, and enroll the child only after the parent or guardian agrees. For this study, however, it is not possible to explain the study details and obtain parental permission in
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