Completed
Use of Lorazepam for the Treatment of Status Epilepticus
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2016-05-23
69
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead Sponsor
T
The Emmes Company, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Brief Title
Lorazepam for the Treatment of Status Epilepticus in Children
Who Can Participate
Eligibility Criteria
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
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