The research study was designed to determine which of two drugs is best when treating children in distress who display a continuous, unrelenting seizure, also known as status epilepticus.
The hospitals are prepared to access a computer that will randomly assign the decision for doctors to provide either Valium or Ativan within five minutes to children entering the emergency room with a status epilepticus diagnosis.
The swift timeframe for treatment will not allow parents any decision making in the process in an effort to minimize the chances of these children from further imminent danger of brain damage or death.
Currently, parents are not consulted as to the specific drug treatment in these cases anyway. Normally the parents are simply informed that their child is receiving drug treatment for the seizures, not specifics as to what kind of drug.
Usually participants are enrolled in studies with prior consent. However, under the circumstances, these children will automatically be enrolled in the study if they meet the criteria, unless parents notify the hospital in advance that they do not wish their children to participate.
According to the U.S. National Institutes of Health, the government agency funding this study, there are no added risks involved, and study participants will not be required to make further visits. Follow-ups will merely be made via telephone interviews.
Parents will be notified after the child has already been enrolled in the study and after the child's condition is stabilized. Upon receiving this information, the parents will be asked if they would like to continue participating. Parents will have the right to refuse further participation.
However, researchers are hopeful that parents will cooperate as they seek to find the answer to the best treatment for this emergency medical condition.
The length of the study will be determined by the outcome based on the confidence of researchers to have enough information to determine which of the two drugs has been the most effective.
The study sites are listed on the government's website at http://www.nichd.nih.gov/news/releases/study_pediatric_seizure_QA_052207.cfm .
