Lorazepam for the Treatment of Status Epilepticus in Children
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ClinicalTrials.gov Identifier: NCT00114569 |
Recruitment Status :
Completed
First Posted : June 16, 2005
Last Update Posted : May 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Status Epilepticus | Drug: lorazepam | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Lorazepam for the Treatment of Status Epilepticus |
Study Start Date : | March 2005 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | February 2009 |

- Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam
- safety of IV lorazepam

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Ages Eligible for Study: | 3 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114569
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | James Chamberlain, MD | Children's National Medical Center, Washington, D.C. |
Responsible Party: | James Chamberlain, Children's National Medical Center |
ClinicalTrials.gov Identifier: | NCT00114569 |
Other Study ID Numbers: |
HHSN275200403393C HHSN275200403393C |
First Posted: | June 16, 2005 Key Record Dates |
Last Update Posted: | May 23, 2016 |
Last Verified: | May 2009 |
children status epilepticus lorazepam |
safety pharmacokinetics status epilepticus in children |
Status Epilepticus Seizures Neurologic Manifestations Nervous System Diseases Lorazepam Anticonvulsants Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |