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Pediatric Seizure Study Underway in US to Decide Between Diazepam and Lorazepam

advance because of the urgent need to provide treatment within 5 minutes of the childs arrival in the emergency department. Moreover, status epilepticus may occur when a child is away from his or her parents; a parent may not be present when the child is taken to the emergency department.

Children admitted to participating institutions and who meet study criteria will be automatically enrolled in the study without prior parental consent. Dr. Baren stressed that this sequence of events is little different than what would take place in an emergency department not involved in the study. Under typical circumstances, the admitting physician would decide on whether the patient would receive lorazepam or diazepam. In the study, a computer program will decide which drug the child received. The principle is to assign the drug without any preference, to avoid any potential human bias. At the end of the study, roughly equal numbers of children will have been assigned to receive each drug, and a large enough number of children will have been studied to allow the researchers to draw definitive conclusions about each medication.

After the doctor has made sure that the child has received treatment and has been stabilized, the doctor or a representative from the study team will contact the parent to let them know that his or her child has been enrolled in this study. At this time, the details of the study will be explained to the parent, and the parent can choose to allow the child to continue in the study or can withdraw the child from the study.

If the parent agrees to continue, small blood samples will be taken from the child and the parent will be interviewed by phone 48 hours later and then 30 days after the child is enrolled to ask about the childs condition.

The independent board or research review committee at each hospital will oversee the study and ensure that all procedures comply with ethics and safety standards. Other indepen
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