Few things are more frightening for a parent than seeing their child experience a seizure. For the parent and for the paramedics who arrive on the scene, the primary goal is to stop the child’s seizure.

That’s why researchers Lerner and Clemency — who both practice at UBMD Emergency Medicine — are leading a project designed to determine how to achieve that more quickly, even when on the way to the hospital.

The Pediatric Dose Optimization for Seizures in Emergency Medical Services study, or PediDOSE, which is being conducted in 20 cities, is funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.

“The longer the seizure goes on, the more negative outcomes the child may experience,” says Lerner. “Our preliminary work showed that children experiencing a seizure outside of a hospital often do not receive enough medication to effectively stop the seizure.”

“The aim of this study is to evaluate an easier-to-use method for determining proper medication dose for a seizing child,” Lerner continues.

“This method does not require calculations and can be done more quickly. We believe it will be more likely to stop the seizure before a child reaches the emergency department,” she adds.

Lerner and Clemency are pioneering Buffalo’s efforts to help these seizure patients. They are working with 20 other EMS systems serving sites in the Pediatric Emergency Care Research Network (PECARN) across the country and with American Medical Response, an emergency medical services company that operates in Western New York.

“Currently, one-third of actively seizing children are still seizing by the time they reach the emergency department,” says Lerner. “This may be due to an inadequate dosage or delay in administering medication, so it fails to stop the seizure.”

Lerner, along with the other principal investigators in this project, hypothesize that underdosing of medications may be attributed to the practice of calculating the dosage based on the child’s weight. Instead, they believe that standardized age-based dosing may be a more effective and efficient way to treat patients.

This method eliminates the multi-step calculations of weight-based dosing.

“We found that maybe we don't need to be calculating the dose based on weight, especially since the child or whomever they are with may not know their weight and it can be hard to guess it,” says Lerner. “But, most people who are with the child will know the child’s age.”

“Seizures are a common reason people call an ambulance for a child. So if this study shows that standardized, age-based dosing is more effective in comparison to the current practice, then this research could positively impact the lives of countless children and their parents. This study could improve seizure treatment protocols for ambulance services nationwide,” says Allison Brashear, MD, UB’s vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences.

The study requires a change in protocol and practice. Usually, the participant’s informed consent must be obtained before any intervention can occur, including administering medication. Informed consent in a research study involves a detailed consent form, which the participant can study and discuss with their own provider if they wish before deciding whether to give consent.

However, in emergency situations, that isn’t feasible due to the speed with which medication must be delivered and the environment, which may be the ambulance or the emergency department. Therefore, federal regulations allow for investigators to conduct this study using an exception from informed consent in emergency research. These regulations allow individuals to be enrolled in the study without consent as long as the community is notified of the study and given the opportunity to provide feedback, and enrolled individuals are notified of their participation as soon as it is feasible.

“Children can’t consent to participate in the study because they are not of legal age,” Lerner notes. “Even with an adult present, having your child seize is not a moment when you can make an informed decision about research.”

For these reasons, Lerner explains, the research team will spend the next several months focused on educating the Buffalo community about this study and who it will benefit.

“Our plan includes conducting educational interviews with parents who arrive at the Oishei Children’s Hospital Emergency Department, collaborating with the Epilepsy Society and other organizations of affected families, and posting advertisements and educational materials through the media and other patient networks,” says Lerner.

The study, which begins in May, will collect data over the next four years.

“This study has the potential to have a very big impact on prehospital care across the country,” emphasizes Lerner. “Our primary goal is to ultimately improve pediatric prehospital seizure care.”

In addition to Lerner and Clemency, other UB faculty involved in the study include:

• Michelle D. Penque, MD, clinical associate professor of pediatrics 
• Arie L. Weinstock, MD, professor of clinical neurology
• Bree C. Kramer, DO, clinical associate professor of pediatrics