Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

NCT00735527 | Completed Phase 3 DMC

• 1 other identifier: INLOR
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus; Seizures

Keywords

seizures; status epilepticus; lorazepam; intra-nasal

Outcome Measures

Primary Outcomes (1)

• Cessation of all clinical seizure activity within 10 min of drug administration

  10 min

Secondary Outcomes (6)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Lorazepam

2

ACTIVE COMPARATOR

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

Drug: Lorazepam

Interventions

Lorazepam DRUG

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

1

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

• Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.

  PMID: 21275979 DERIVED

MeSH Terms

Conditions

Status Epilepticus; Seizures

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 15, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 5, 2009

Record last verified: 2009-05

Locations

IN (1)