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| Sponsor: | All India Institute of Medical Sciences, New Delhi |
|---|---|
| Information provided by: | All India Institute of Medical Sciences, New Delhi |
| ClinicalTrials.gov Identifier: | NCT00735527 |
Purpose
Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Status Epilepticus Seizures |
Drug: Lorazepam |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial |
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
|
Drug: Lorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
|
|
2: Active Comparator
Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
|
Drug: Lorazepam
Intra-venous 0.1 mg/kg (maximum 4 mg) once
|
Eligibility| Ages Eligible for Study: | 6 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | All India Institute of Medical Sciences ( Ravindra Arya ) |
| Study ID Numbers: | INLOR |
| Study First Received: | August 12, 2008 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00735527 History of Changes |
| Health Authority: | India: Ministry of Health |
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seizures status epilepticus lorazepam intra-nasal |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Antiemetics Brain Diseases Lorazepam Signs and Symptoms Status Epilepticus Therapeutic Uses Hypnotics and Sedatives Tranquilizing Agents Nervous System Diseases |
Seizures Gastrointestinal Agents Central Nervous System Depressants Central Nervous System Diseases Pharmacologic Actions Epilepsy Autonomic Agents Neurologic Manifestations GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |