What we learned
We are physicians and researchers who have been working to find the best way to care for children with seizures in the emergency department. We belong to a partnership of 14 children’s hospitals and universities from across the country.
To learn more about the study, see the Q & A below and visit the following pages:
Downloadable Brochure
Q & A
Why we did this study?
How were children enrolled in the study?
How many children were enrolled in the study?
Which is better: Lorazepam or Diazepam?
Why we did this study?
By the age of 15, 4 to 8 percent of children experience a seizure episode. Seizures can be life threatening if they are not stopped immediately. Currently, Lorazepam and Diazepam are commonly prescribed by doctors for treating seizures in children. Lorazepam has been approved by the Food and Drug Administration (FDA) for adults, but has not yet been approved for use in children. Doctors have been able to use Lorazepam “off-label” to safely treat children for years.
“Off-label” means the medication’s label does not specifically say that it can be used in children. Doctors do not need to follow the label on a medication. They can prescribe an FDA approved medication for any patient. Off-label use is very common in children because drug studies in children take a very long time and are difficult.
Both medicines are effective in treating seizures but cause a slowing in breathing, a condition called respiratory depression. However, many experts support the use of Lorazepam over Diazepam.
We conducted 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 was funded by the National Institute for Child Health Development (NICHD) of the National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA) under BPCA.
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How were children enrolled in the study?
Normally, researchers contact a child’s parents or guardians before the child can participate in a study. The design of the study, and its potential risks and benefits, are explained to them and their consent is obtained.
For this study, however, it is not possible to obtain parental consent in advance. These medications must be given within 5 minutes of a child’s arrival in the ED, so there might not be enough time to talk to a child’s parent/guardian about the study. In that case, a child may be enrolled in the study without a parent’s permission.
If a child who met the study criteria was seizing when he or she arrived in the ED, a doctor would evaluate the child and he or she would be enrolled in the study automatically. This is similar to the way children are treated now, because both Lorazepam and Diazepam are commonly prescribed. The only difference is that the medication would be chosen at random, not by the doctor.
After the doctor made sure that the child had been treated medically, the doctor or a representative from the study team contacted the parent to let them know that his/her child was enrolled in this study. At this time, the parent was given all of the details about the study and could choose to continue or refuse the child’s participation.
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How many children were enrolled in the study?
Children between the ages of 3 months to 18 years of age with prolonged seizures who were being treated in the participating hospitals’ ED were included in this study.
A total of 310 children were enrolled nationwide during a four-year period from March 2008-2012.
The chart below shows the distribution of these patients across all our participating sites.
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Which is better: Lorazepam or Diazepam?
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