Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Status Epilepticus
About this trial
This is an interventional treatment trial for Status Epilepticus
Eligibility Criteria
Inclusion Criteria:
- Age 3 months to less than 18 years;
Generalized tonic clonic status epilepticus, defined as:
- Three or more generalized tonic clonic seizures within the last hour and currently experiencing a convulsion (i.e. the current convulsion may be the third convulsion within one hour); or
- Two or more generalized tonic clonic seizures in succession with no recovery of consciousness between seizures and currently experiencing a convulsion (i.e. the current convulsion may be the second convulsion without recovery of consciousness after the first convulsion); or
- A seizure that lasts at least 5 minutes that is either generalized tonic clonic in its entirety or starts focal and then generalizes. The seizure must be associated with loss of consciousness
Exclusion Criteria:
- Pregnancy;
- Shock prior to study drug (sustained hypotension requiring inotropic therapy);
- Significant dysrhythmia prior to study drug (other than sinus tachycardia);
- Need for emergent surgical intervention and general anesthesia for a condition present prior to study drug;
- Known sensitivity to benzodiazepines or known contraindication to benzodiazepine use; or
- Use of a benzodiazepine within 1 week of presentation.
Certain exclusion criteria may not be known at the time of drug administration due to the need for emergent treatment. Thus patients will be terminated from the study (early terminators) if the investigators discover any of the following conditions after administration of study drug:
- Pregnancy;
- Use of a benzodiazepine within 1 week of presentation.
- Parent/guardian refusal to give informed consent by the methods described;
- Patient's refusal to assent (for patients ≥ 7 yrs old and mentally competent to understand study procedures) by the methods described, or as required by the local IRB;
Sites / Locations
- University of California- Davis Medical Center
- Children's Hospital Colorado
- Children's National Medical Center
- University of Maryland Hospital for Children
- University of Michigan Emergency Medicine Research
- Children's Hospital of Michigan
- Children's Hospital of Buffalo
- Children's Hospital of Philadelphia
- Children's Medical Center Dallas
- Texas Children's Hospital
- University of Utah Pediatric Emergency Medicine
- Medical College of Wisconsin Children's Corporate Center
- Alberta Children's Hospital
- Children's Hospital of Eastern Ontario
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cohort 1
Cohort 2
Cohort 1 (preconsented) patients will involve obtaining informed consent from the legally authorized representative of a potential study subject before they present to the ED in SE. Patient assent will be obtained for patients as per local IRB rules. The consent document (enclosed in this application) will inform parents that if their child comes to the ED and qualifies for the study based on study inclusion/exclusion criteria, they will be enrolled. Patients who cannot be contacted to confirm consent will be enrolled in Cohort 2 (EFIC) as detailed below. Patients in Cohort 1 will be randomized in a blinded fashion to either lorazepam 0.1 mg/kg or diazepam 0.2 mg/kg
Cohort 2 (EFIC) will include patients who appear in the ED with SE and qualify for the study but have not given prior consent. These patients will be enrolled under the EFIC regulations. The parent/guardian will be given the opportunity to object to participation or ask additional questions. The child will be enrolled (dosed) with study medication under an EFIC. Once the child is stabilized, a research staff member will approach the parent or LAR to obtain informed consent to continue the child's participation in the study. If a parent or LAR refuses continued participation, then no further study procedures will be performed. Safety and data will be collected in accordance with federal regulations. Cohort 2 will be randomized, like Cohort 1, to either lorazepam 0.1 mg/kg or diazepam 0.2 mg/kg