Nasal vs. venous lorazepam for control of acute seizures in children

Phase 3

• Conditions: Status epilepticusacute seizures

• Registration Number: CTRI/2008/091/000135
• Lead Sponsor: All India Institute of Medical SciencesAnsari Nagar, New Delhi

Brief Summary

Status epilepticus (SE) is a common pediatric emergency which requires rapid termination of seizures. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam, administered by intravenous (IV) route is the standard of care as first line therapy for control of seizures in SE. We intend to compare efficacy and adverse effect profile of intranasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for venous cannulation is not available. Alternate route of administration (intranasal) if shown equivalent to conventional IV route, will be very useful for management of seizures in children in emergency room, in patient or out of hospital settings.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Children presenting convulsing to the pediatric emergency or developing seizure while in casualty Age 6-14 yrs.

Exclusion Criteria

Known hypersensitivity to any benzodiazepine Child has received any parenteral anti-convulsant within 1 hr prior to enrolment Presence of severe cardio-respiratory compromise or cardiac arrhythmiasPresence of upper respiratory tract infection Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cessation of all clinical seizure activity within 10 min of drug administration	10 min

Secondary Outcome Measures

Name	Time	Method
Persistent cessation of seizure activity for 1 hr	1 hour

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Ravindra Arya

Principal investigator

09717578673

ravindra.arya4@gmail.com