Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Lorazepam

Criteria

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