Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-04-30

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.

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Detailed Description

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Conditions

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Status Epilepticus Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)

Group Type EXPERIMENTAL

Lorazepam

Intervention Type DRUG

Intra-nasal 0.1 mg/kg (maximum 4 mg) once

2

Intra-venous lorazepam 0.1 mg/kg (max 4 mg)

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

Intra-venous 0.1 mg/kg (maximum 4 mg) once

Interventions

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Lorazepam

Intra-nasal 0.1 mg/kg (maximum 4 mg) once

Intervention Type DRUG

Lorazepam

Intra-venous 0.1 mg/kg (maximum 4 mg) once

Intervention Type DRUG

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No