Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
- Registration Number
- NCT00735527
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
- Age 6-14 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Lorazepam Intra-venous lorazepam 0.1 mg/kg (max 4 mg) 1 Lorazepam Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
- 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 hr Time to achieve intra-venous access after arrival in casualty minutes Patients requiring rescue medication within 1 hr 1 hr Time from drug administration to termination of seizure(s) minutes Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration 1 hr Development of significant respiratory depression requiring assisted ventilation 1 hr
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India