Emergency Seizure Treatment Study For Kids Under Way
A new study under way at the University of Michigan Health System and 10 other hospitals around the country will give doctors the answer to an important question: Which emergency treatment is best for children who suffer severe, prolonged seizures that can be life-threatening?
The study will compare two drugs that are already used every day in emergency rooms around the country to treat seizures in children with a condition called “status epilepticus.” Many of these children already have epilepsy, while others are suffering a first-time seizure — for instance, one associated with a bad infection.
But because the drugs must be given within moments of a seizing child’s arrival at the hospital — without enough time to fully explain the study to a parent or guardian, or to get his or her consent to enroll the child in the study — many special steps have been taken to prepare for the study’s launch.
To gauge the community’s reaction to the idea of such a study, U-M children’s emergency medicine experts have conducted an extensive outreach effort in recent months that consulted with families and community members, and notified the public. They have also developed a detailed set of instructions for doctors and nurses in the 24-hour U-M Pediatric Emergency Division, to make sure the study is carried out in accordance with the federal laws and U-M guidelines that govern it.
This also includes an “opt-out” list that parents can add their children to, so that doctors will know they should not be included in the study if they are brought to a participating hospital with a seizure. Parents can call 877-661-4666 to add their child to the list.
These steps, and others, make the study the first of its kind to be conducted at U-M — a study in which informed consent is not obtained prior to starting study procedures. After a seizing child has been stabilized, his or her parent or guardian will be given the choice about whether to continue the child’s participation in the study.
The goal of such studies is to give doctors and parents better options, guided by science, for the treatment of life-threatening conditions — and to improve an area of children’s emergency care that has rarely been studied. Studies must be done this way when patients with life-threatening illnesses require immediate treatment but are unconscious or otherwise unable to give permission, and family members or legal representatives are unavailable or unable to give consent.
One year ago, the panel that oversees research studies involving humans at U-M voted to allow such studies, which have been permissible under U.S. Food and Drug Administration rules for over a decade.
Before the seizure study could begin, that panel — the Medical School’s Institutional Review Board, or IRB-MED — required the study’s leaders to show that they have fulfilled U-M and government requirements needed to carry out their study. The panel will monitor the study as it progresses.
The umbrella term for such emergency-treatment studies is EFIC, because they are performed under an “exception from informed consent,” first permitted in 1996 by the FDA. Other EFIC studies around the country have, for example, shown that automated defibrillators in public places can save people from sudden cardiac death by shocking the heart back into rhythm.
Rachel Stanley, M.D., MHSA, heads the seizure study at U-M. Ten other hospitals around the nation, including Children’s Hospital of Michigan in Detroit, are also taking part. Stanley, an assistant professor of emergency medicine and pediatrics at U-M, directs the Great Lakes Node of the Pediatric Emergency Care Applied Research Network, which is based at U-M.
“While we know that both of these drugs work and both are used in emergency rooms to stop seizures, we think one may be better than the other. But we need this study to show whether that is true. The results will help guide treatment of children around the country,” says Stanley. “The response we received during our conversations with parents and children over the past few months was very positive, and encouraged us to proceed with the study as planned.”
The two drugs in the study are lorazepam (often known as Ativan) and diazepam (often known as Valium). Both are used in emergency rooms around the country every day to treat children for seizures, but only diazepam has been approved by the FDA for the treatment of seizures in children. Even so, many doctors prefer lorazepam for this condition.
The study seeks to determine in a scientific manner which drug is more effective and safe, by randomly assigning children to receive one or the other.
A study team member will talk with the family as soon as possible after the child is treated, and at any time the parent or guardian can ask for a child’s participation in the study to end. Families will be compensated for the time they spend participating in the study.
“It’s important for families to realize that if they request in advance not to participate, or decline to sign the consent form for the additional portions of the study, their child will receive the same high level of care that they would have received even if the study were not being conducted,” says Stanley.