Status Epilepticus Clinical Trial
Official title:
Use of Lorazepam for the Treatment of Status Epilepticus
The purpose of this study is to gather the data to: 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study (study of how much drug is found in the body after it is given through a vein and how fast the body gets rid of the drug).
Status | Completed |
Enrollment | 69 |
Est. completion date | February 2009 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 17 Years |
Eligibility |
Inclusion Criteria: - Generalized tonic clonic seizures within 1 hour OR 2 or more generalized tonic clonic seizures in rapid succession with no recovery of consciousness between seizures OR a single ongoing generalized tonic clonic seizure which has lasted at least 5 minutes Exclusion Criteria: - Inability to obtain informed consent or assent - Sustained hypotension - Significant arrhythmia - Known hypersensitivity to or contraindication to use of benzodiazepines - Use of lorazepam within 4 days of study drug dosing - American Association of Anesthesiology (ASA) Class > 1 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | The EMMES Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam | |||
Secondary | safety of IV lorazepam |
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