Seizures, Status Epilepticus
Conditions
Keywords
seizures, status epilepticus, lorazepam, intra-nasal
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.
Interventions
DRUGLorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of all clinical seizure activity within 10 min of drug administration | 10 min |
Secondary
| Measure | Time frame |
|---|---|
| Patients requiring rescue medication within 1 hr | 1 hr |
| Time to achieve intra-venous access after arrival in casualty | minutes |
| Persistent cessation of seizure activity for 1 hr | 1 hr |
| 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 |
| Time from drug administration to termination of seizure(s) | minutes |
Countries
India
Outcome results
None listed