Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children (INLOR)

All India Institute Of Medical Science (AIIMS)

Status and phase

Completed

Phase 3

Conditions

Seizures

Status Epilepticus

Treatments

Drug: Lorazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT00735527

INLOR

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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