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About the Study - Seizure Study - Clinical Trials - Research
We are physicians and researchers who are working toward finding the best way to care for children with seizures in the emergency room. We belong to a partnership of 10 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
Our Research Network
Q & A
Why are we doing this study?
How would children be enrolled in the study?
What are the benefits of participation?
What are the risks of participation?
What if I do not want my child to participate?
Who may be enrolled in the study?
Where can I learn more about the study?
Will I be compensated for participating?
Which drug will my doctor give if I choose not to participate in this study?
Will the doctor give Lorazepam?
Can I choose which drug my child receives in the study if my child participates?
What if there is an emergency and we need to know what drug my child received?
What if I do not want my child to participate?
Why are we doing this study?
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. 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 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 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 would children be enrolled in the study?
Seizure medication has to be given within five minutes of a child’s arrival in the ER 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 present.
If a child is seizing when he or she arrives in the ER, a doctor will evaluate the child to see if he or she qualifies for the study. If the child qualifies, he or she would be enrolled in the study automatically and would get one of the two medicines chosen at random. 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 has made sure that the child has been treated medically, the doctor or a representative from the study team will contact the parent to let them know that his/her child has been enrolled in this study. At this time, the parent will be given all of the details about the study and can choose to continue or refuse the child’s participation.
What are the benefits of participation?
Because we do not know which medicine is better, a child may benefit from receiving a better medicine. The child also will receive extra medical monitoring beyond regular medical care. This includes our medical team taking extra vitals signs and other physical examination assessments.
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What are the risks of participation?
There are very few risks of participating in this study. The medical staff have received extensive training about proper administration of these particular medications. Every healthcare provider is committed to providing the safest environment for all children in the ER.
The medication being studied is already used to treat children with seizures. Lorazepam and Diazepam have similar side effects, such as respiratory depression, sleepiness, muscle cramps, anxiety, dizziness, and visual hallucinations. The healthcare team will monitor your child for side effects.
Study participation also includes getting small blood samples from the child, but the staff would not do that without permission. The last part of the study is a telephone interview 48 hours and then 30 days after the child is enrolled. We would not call the parents without their permission.
As part of this study, parents would not be required to return to the hospital for any additional visits – the telephone interview would end the child’s participation in this study.
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What if I do not want my child to participate?
If you do not want your child to participate, you can let us know in three ways:
- Call us at 1-866-377-8557.
- Fill out the participant refusal form .
- If you are with your child when he or she comes to the ER, you can let the doctor know that you do not want to participate.
Please note that if you inform us ahead of time that you do not want to participate, we will ensure your child is not enrolled if your child arrives in the ER seizing. For example, some sites will mail you a bracelet that your child can wear to identify that he or she is not participating in the study. While your child does not have to wear the bracelet, we strongly suggest that he or she does. We don’t always know a child’s name when we first treat them in the ER. Our focus is on immediately treating your child’s medical condition. That is why he or she must wear the bracelet so we can make sure your child is not enrolled in the study.
If your child does not participate in the study and comes to an ER at a participating center, the doctor will choose which seizure medicine to give. The doctor in the ER will treat your child as they normally would to control seizures. Please note that the doctor could still give your child Lorazepam, if he or she chooses. And, if you want your child to receive Lorazepam, you can ask for it.
Who may be enrolled in the study?
Children between the ages of 3 months to 18 years of age with prolonged seizures who are treated in the participating hospitals’ emergency rooms may be included in this study.
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Where can I learn more about the study?
Before the study starts, some of the sites will hold community meetings to provide information, answer questions and obtain community feedback about the study. Click here for a schedule of meetings .
Will I be compensated for participating?
Compensation will vary depending on the participating hospital.
Which drug will my doctor give if I choose not to participate in this study?
Your child’s doctor will decide which drug to give based on his or her best judgment.
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Will the doctor give Lorazepam?
The doctor may give Lorazepam if he or she feels it is appropriate to do so.
Can I choose which drug my child receives in the study if my child participates?
Neither you nor the doctor can choose which drug your child receives. The reason is we must ensure there is no bias in the research study (i.e. we have to make sure that the doctor is not influenced in his or her decision making because he or she thinks one drug is better). In order to make sure that a doctor’s personal opinion does not affect his/her evaluation of how soon your child’s seizure stopped, we don’t let you or your doctor know which drug your child received.
What if there is an emergency and we need to know what drug my child received?
In an emergency situation, we have a hotline (1-866-377-8557) that your doctor can call at any time to find out which drug your child received.
However, since both Lorazepam and Diazepam are benzodiazepines and in order to participate in the study, your child’s doctor must feel that it is necessary to treat him or her with a benzodiazepine, the risks to your child are roughly the same with both medications.
What if I do not want my child to participate?
Call us or fill out the participant refusal form if you do not want your child to participate in the study. Your child will still receive the best possible care if he or she comes to the emergency room with a seizure.
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