Houston, TX (Mar. 30, 2010) – Researchers at Texas Children’s Hospital and Baylor College of Medicine are joining 13 other children’s hospitals and universities in the United States and Canada to determine which of two commonly prescribed medications is the most effective treatment for a serious seizure disorder seen in the emergency room.

The condition, called status epilepticus, results in continuous, unrelenting seizures, which, if not treated within a few minutes, can lead to brain damage or even death. The condition must be treated within five minutes or less of a child’s arrival in the emergency room.

Children with status epilepticus who are admitted to the emergency room at Texas Children’s Hospital will be assigned at random to receive one of two commonly prescribed treatments.

Lorazepam (Ativan) has been approved by the U.S. Food and Drug Administration to treat adult seizures, but it is widely prescribed to treat children. Diazepam is approved for use in adults and children.

No large scale comparisons of the drugs have been conducted in childhood seizure patients and it is not known which of the two drugs is the most effective in the treatment of pediatric seizures.

Because of the urgent need to administer treatment within five minutes of a child’s arrival in the emergency room, it will not be possible to obtain permission from a child’s parent or guardian before the child is enrolled 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 involved, potential risks, benefits, and alternatives, and enroll the child only after the parent or guardian agrees. Moreover, status epilepticus may occur when a child is away from his or her parents, so they may not be present when the child is taken to the emergency room.

After the child has been stabilized and the parents have been contacted, the parents may choose to either allow the child to continue in the study or may choose not to participate. Parents may contact hospital officials in advance and inform them that they do not wish their child to participate.

“The drugs in the study come from the same class and they work in similar ways,” said Dr. Charles Macias, who will lead the local study, and is an associate professor of pediatrics – emergency medicine at BCM. “At the end of the study, we hope to identify the most effective and appropriate treatment for children.”

Approximately 50,000 to 200,000 cases of status epilepticus occur in children and adults in the United States each year.

Once they have received consent, the researchers will take blood samples from the children and plan to interview the parents/guardians within 30 days of the treatment.
Under federal regulations, the researchers must notify all relevant communities (parents and children affected by these recurrent seizures) about the study and seek their feedback on it.

For more information, to provide feedback or to inform researchers that you do not want your child to be enrolled in this study, please visit www.dcchildrens.com/seizurestudy or call 1-866-377-9557.

The study is supported by the National Institutes of Health. For more information about the study, please visit www.nichd.nih.gov/news/releases/study_pediatric_seizure_052207.cfm.

In addition to Texas Children’s, other hospitals participating in the study include Children’s National Medical Center in Washington D.C.; University of Maryland Hospital for Children in Baltimore, Md.; Children’s Hospital of Philadelphia; Women and Children’s Hospital of Buffalo; Children's Hospital of Eastern Ontario in Ottawa; Children’s Hospital of Wisconsin in Milwaukee; University of Michigan Health System in Ann Arbor; Children’s Hospital of Michigan in Detroit, Alberta Children’s Hospital; Primary Children’s Hospital in Salt Lake City, Utah; University of California Davis Medical Center; Children’s Medical Center in Dallas, Texas; and The Children’s Hospital Denver in Aurora, Colo.

About Texas Children’s Hospital
Texas Children's Hospital is committed to a community of healthy children by providing the finest pediatric patient care, education and research. Renowned worldwide for its expertise and breakthrough developments in clinical care and research, Texas Children’s is ranked in the top ten best children’s hospitals by U.S. News & World Report. Texas Children’s also operates the nation’s largest primary pediatric care network, with more than 40 offices throughout the greater Houston community. Texas Children’s has embarked on a $1.5 billion expansion, Vision 2010, which includes a comprehensive neurological research institute, the formation of a maternity center, and the development of the new West Campus, Texas Children’s first pediatric hospital in a suburban setting. For more information on Texas Children's Hospital, go to www.texaschildrens.org. Get the latest news from Texas Children’s Hospital by visiting the online newsroom and on Twitter at twitter.com/tch_news.