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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00621478 |
Purpose
Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.
| Condition | Intervention | Phase |
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Status Epilepticus |
Drug: lorazepam or diazepam |
Phase II Phase III |
| Genetics Home Reference related topics: | pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy |
| MedlinePlus related topics: | Seizures |
| Drug Information available for: | Diazepam Lorazepam |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam |
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Cohort 1: Active Comparator
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 |
Drug: lorazepam or diazepam
Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing. The medication will be administered as a slow IV push. |
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Cohort 2: Active Comparator
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 |
Drug: lorazepam or diazepam
Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing. The medication will be administered as a slow IV push. |
Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles. In the prehospital (Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without refrigeration.
The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA.
Eligibility
| Ages Eligible for Study: | 3 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Generalized tonic-clonic status epilepticus, defined as one or more if the following:
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 diazepam or lorazepam within 1 week of presentation.
Contacts and Locations| Contact: James Chamberlain, MD | 202-476-3253 | jchamber@cnmc.org |
| United States, District of Columbia | |||||
| Children's National Medical Center | Recruiting | ||||
| Washington DC, District of Columbia, United States, 20010 | |||||
| Contact: Jim Chamberlain, MD 202-476-3253 jchamber@cnmc.org | |||||
| Principal Investigator: | James Chamberlain, MD | Childrens Research Institute |
More Information
| Responsible Party: | Children's National Medical Center ( Jim Chamberlain, MD/ Principal Investigator ) |
| Study ID Numbers: | N01HD043393, 275200403393C |
| First Received: | February 20, 2008 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00621478 |
| Health Authority: | United States: Food and Drug Administration |
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