Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Seizures Clinical Trial

— INLOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735527
• Other study ID #: INLOR
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2008
• Last updated: May 4, 2009
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Seizures
• Status Epilepticus

Intervention

Drug:
• Lorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
• Lorazepam
Intra-venous 0.1 mg/kg (maximum 4 mg) once

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of all clinical seizure activity within 10 min of drug administration		10 min	No
Secondary	Persistent cessation of seizure activity for 1 hr		1 hr	No
Secondary	Patients requiring rescue medication within 1 hr		1 hr	No
Secondary	Time to achieve intra-venous access after arrival in casualty		minutes	No
Secondary	Time from drug administration to termination of seizure(s)		minutes	No
Secondary	Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration		1 hr	Yes
Secondary	Development of significant respiratory depression requiring assisted ventilation		1 hr	Yes