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

Sponsor

All India Institute of Medical Sciences, New Delhi (Other)

Overall Status

Completed

CT.gov ID

NCT00735527

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Status Epilepticus Seizures	Drug: Lorazepam Drug: Lorazepam	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)	Drug: Lorazepam Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Active Comparator: 2 Intra-venous lorazepam 0.1 mg/kg (max 4 mg)	Drug: Lorazepam Intra-venous 0.1 mg/kg (maximum 4 mg) once

Arm

Intervention/Treatment

Experimental: 1

Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)

Drug: Lorazepam

Intra-nasal 0.1 mg/kg (maximum 4 mg) once

Active Comparator: 2

Intra-venous lorazepam 0.1 mg/kg (max 4 mg)

Drug: Lorazepam

Intra-venous 0.1 mg/kg (maximum 4 mg) once

Outcome Measures

Primary Outcome Measures

Cessation of all clinical seizure activity within 10 min of drug administration [10 min]

Secondary Outcome Measures

Persistent cessation of seizure activity for 1 hr [1 hr]
Patients requiring rescue medication within 1 hr [1 hr]
Time to achieve intra-venous access after arrival in casualty [minutes]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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