drugset / Trial / NCT00735527

Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

NCT00735527

Phase 3 Completed 140 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-05
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lorazepam Small molecule 0.1 mg/kg Intranasal

Indications