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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intra-nasal lorazepam 0.1 mg/kg (max 4 mg) |
|
| 2 | Active Comparator | Intra-venous lorazepam 0.1 mg/kg (max 4 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorazepam | Drug | Intra-nasal 0.1 mg/kg (maximum 4 mg) once |
| |
| Lorazepam |
| Measure | Description | Time Frame |
|---|---|---|
| Cessation of all clinical seizure activity within 10 min of drug administration | 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent cessation of seizure activity for 1 hr | 1 hr | |
| Patients requiring rescue medication within 1 hr | 1 hr | |
| Time to achieve intra-venous access after arrival in casualty |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21275979 | Derived | Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28. |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
Intra-venous 0.1 mg/kg (maximum 4 mg) once |
|
| minutes |
| Time from drug administration to termination of seizure(s) | minutes |
| Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration | 1 hr |
| Development of significant respiratory depression requiring assisted ventilation | 1 hr |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |