News | May 14, 2008

Clinical Trial Underway to Determine Safety, Efficacy of Common Drugs for Pediatric Seizures

May 15, 2008 - Children's Medical Center Dallas, along with its research partner, UT Southwestern, will be participating in a study to test the effectiveness of Lorazepam as compared to Diazepam, two drugs commonly used to treat prolonged or repeated seizures in children.

Researchers from the Perot Center for Brain and Nerve Injury at Children's will be conducting a trial on the drug therapies.

"We are honored to participate in this trial," said Dr. Pam Okada, associate professor of pediatrics at UT Southwestern, emergency room physician at Children's and lead investigator on the double-blind trial. "Both therapies have been used for years to treat seizures in children, but now we can gather hard data on the effectiveness of both medications so that physicians all over the world can make more informed decisions about the care of their patients with prolonged or repeated seizures."

By the age of 15, four to eight percent of children experience a seizure episode. Seizures can be life threatening if they are not stopped immediately. They may occur in patients with a known seizure disorder, such as epilepsy, or in patients without epilepsy who experience a febrile seizure, metabolic imbalance, acute infection of the central nervous system, or a traumatic head injury. Lorazepam and Diazepam are both medications 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.

Children ages three months to 18-years-old who are admitted to the emergency department at Children's Dallas with prolonged or repeated seizures are eligible for the study.

Children's Medical Center Dallas will participate in this study along with 10 other U.S. hospitals. The study hopes to enroll 240 patients nationwide. Enrolled patients will be randomized to either Diazepam or Lorazepam treatment. Parents can opt out of the study by letting the emergency room physician know they do not wish to participate, and the child will receive standard of care treatment. Parents also can call the National Study Hotline at (866) 377-8557 if they do not wish their child to participate. The study begins at Children�s in September of this year.

Top pediatric hospitals across the country are conducting this study because it is important to test which medications are most appropriate for pediatric patients. In 2001, Congress passed the Best Pharmaceuticals for Children Act (BPCA) to study medications that are currently used in children but have never been FDA approved.

This study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH), with support from the Emergency Medical Services for Children of the Maternal Child Health Bureau, Health Resources and Services Administration under the BPCA.

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