Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Study Overview
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Brief Summary
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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.

Official Title
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Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial

Conditions
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Status Epilepticus, Seizures

Intervention / Treatment
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* Drug: Lorazepam
* Drug: Lorazepam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children presenting convulsing to the pediatric emergency or developing seizure while in casualty Age 6-14 years Exclusion Criteria: Known hypersensitivity to any benzodiazepine Child has received any parenteral anti-convulsant within 1 hr prior to enrollment Presence of severe cardio-respiratory compromise or cardiac arrhythmias Presence of upper respiratory tract infection Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intra-nasal lorazepam 0.1 mg/kg (max 4 mg) | Drug: Lorazepam<br>* Intra-nasal 0.1 mg/kg (maximum 4 mg) once<br>|
| Active Comparator: 2<br>Intra-venous lorazepam 0.1 mg/kg (max 4 mg) | Drug: Lorazepam<br>* Intra-venous 0.1 mg/kg (maximum 4 mg) once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of all clinical seizure activity within 10 min of drug administration |  | 10 min | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seizures, status epilepticus, lorazepam, intra-nasal