Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children | RxWiki

Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Overview[ - collapse ][ - ]

Purpose	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	Status Epilepticus Seizures
Intervention	Drug: Lorazepam Drug: Lorazepam
Phase	Phase 3
Sponsor	All India Institute of Medical Sciences, New Delhi
Responsible Party	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier	NCT00735527
First Received	August 12, 2008
Last Updated	May 4, 2009
Last verified	May 2009

Tracking Information[ + expand ][ + ]

First Received Date	August 12, 2008
Last Updated Date	May 4, 2009
Start Date	May 2008
Estimated Primary Completion Date	April 2009
Current Primary Outcome Measures	Cessation of all clinical seizure activity within 10 min of drug administration [Time Frame: 10 min] [Designated as safety issue: No]
Current Secondary Outcome Measures	Persistent cessation of seizure activity for 1 hr [Time Frame: 1 hr] [Designated as safety issue: No] Patients requiring rescue medication within 1 hr [Time Frame: 1 hr] [Designated as safety issue: No] Time to achieve intra-venous access after arrival in casualty [Time Frame: minutes] [Designated as safety issue: No] Time from drug administration to termination of seizure(s) [Time Frame: minutes] [Designated as safety issue: No] Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration [Time Frame: 1 hr] [Designated as safety issue: Yes] Development of significant respiratory depression requiring assisted ventilation [Time Frame: 1 hr] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Official Title	Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
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 Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Status Epilepticus Seizures
Intervention	Drug: Lorazepam Intra-nasal 0.1 mg/kg (maximum 4 mg) once Drug: Lorazepam Intra-venous 0.1 mg/kg (maximum 4 mg) once
Study Arm (s)	Experimental: 1 Intra-nasal lorazepam 0.1 mg/kg (max 4 mg) Active Comparator: 2 Intra-venous lorazepam 0.1 mg/kg (max 4 mg)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	140
Estimated Completion Date	April 2009
Estimated Primary Completion Date	April 2009
Eligibility Criteria	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
Gender	Both
Ages	6 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00735527
Other Study ID Numbers	INLOR
Has Data Monitoring Committee	Yes
Information Provided By	All India Institute of Medical Sciences, New Delhi
Study Sponsor	All India Institute of Medical Sciences, New Delhi
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	May 2009

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