NCT00735527

Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Status Epilepticus
• Seizures

Interventions

Type	Name	Description
DRUG	Lorazepam	Intra-nasal 0.1 mg/kg (maximum 4 mg) once
DRUG	Lorazepam	Intra-venous 0.1 mg/kg (maximum 4 mg) once

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-08-15
• Last updated: 2009-05-05

Locations

1 site across 1 country: India