AP News, May 23rd, 2007
When children suffer life-threatening seizures, doctors have minutes to decide which of two drugs to use to try to save them _ with no good research on which works better.
Eleven hospitals around the country are beginning a special study to finally answer that question: A computer will randomly assign patients to get either Valium or Ativan within five minutes of arriving in the emergency room.
Because of the time crunch, doctors won't seek parents' permission first. Children brought to those emergency rooms with the unrelenting seizures known as "status epilepticus" will be enrolled in the study automatically.
The National Institutes of Health is funding the unusual study, and announced the plans Wednesday. Participants in medical research almost always must give prior consent, a requirement the government waives in special cases such as study of emergency care.
Parents don't normally get a say in treatment of status epilepticus; they're just told that doctors are administering seizure-treating drugs. At the 11 study hospitals, once a child's seizures stop, parents will be told about the research and asked if they'll continue to participate. The only difference in care is that children who remain in the study will receive additional medical monitoring, the NIH said.
Status epilepticus is a series of continuous, harsh seizures that, if not treated properly, can lead to brain damage or death. It affects up to 60,000 people a year, mostly children, and can strike anyone. Risks include having a high fever, low blood sugar, a central nervous system infection, or a head injury.
For a list of participating hospitals, check: http://www.nichd.nih.gov/news/releases/study_pediatric_seizure_QA_052207.cfm
