Pediatric Dose Optimization for Seizures in EMS (PediDOSE) study
There is an exciting new clinical trial being conducted in collaboration with the Cincinnati Fire Department Emergency Medical Services (EMS): the Pediatric Dose Optimization for Seizures in EMS (PediDOSE) study. In the spring of 2022, we will begin enrolling patients at Cincinnati Children’s Hospital over a period of four years in this multi-center, stepped-wedge design trial to compare paramedic-administered conventional and standardized dosing of midazolam for pediatric seizures in the out-of-hospital setting. Paramedics currently perform multi-step calculations to determine the midazolam dose, which contributes to under-dosing and delayed administration of midazolam. Because of these delays and under-dosing with conventional dosing, 1/3 of patients arrive at emergency departments (EDs) still seizing. Standardized dosing eliminates calculations and utilizes an age-based dose, potentially enabling paramedics to give the correct dose in a timely manner. The trial will be conducted in 20 urban sites through the Pediatric Emergency Care Applied Research Network (PECARN) and its affiliated EMS agencies and children’s hospitals. The study is funded by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH).
To be eligible for enrollment in the study, patients must meet the following general enrollment criteria:
• Age: 6 months to 13 years old
• Actively having a seizure in the presence of a paramedic
• Transported by a participating EMS agency to a participating ED
If eligible, upon ED arrival, patients who are insufficiently responsive to stimuli will have a rapid response electroencephalogram (RR-EEG) device applied to their scalp to assess the primary outcome of seizing and will be monitored for seizure recurrence while in the ED. Because seizures require immediate treatment, we anticipate that in most cases, it will not be possible to obtain informed consent from patients before they are enrolled. Therefore, eligible patients will be enrolled in this trial under the U.S. Food and Drug Administration’s exception from informed consent (EFIC) requirements for emergency research (21 CFR 50.24). These special rules allow research studies in certain emergency situations to be conducted without consent. EFIC can be used only when the person’s life is at risk, the best treatment is not known, the study might help the person, and it is not possible to obtain informed consent from the patient or a legally authorized representative.
The study will not change which medications will be used in the ED to treat seizures; it will only modify how seizures are managed by EMS prior to ED arrival. Apart from the RR-EEG monitoring, which the ED team can choose to consider or not consider in their decision-making, all hospital-based care will be standard and determined by the treatment team as usual. Study patients will be followed by study personnel until they are discharged from the hospital.
Seizures beget more seizures, and ongoing seizures can lead to respiratory failure, neurologic morbidity and death. We believe that this study may help paramedics optimally treat pediatric seizures in the future with a simple and timely method if we determine that standardized dosing is more effective and equally safe when compared to conventional dosing. If you would like to read more about this study, please visit the study website or contact Dr. Lauren C. Riney
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