Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children - Full Text View

Sponsor:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00735527

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	Intervention	Phase
Status Epilepticus Seizures	Drug: Lorazepam	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Cessation of all clinical seizure activity within 10 min of drug administration [ Time Frame: 10 min ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	140
Study Start Date:	May 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	6 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735527

Locations

India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jan 28.

Responsible Party:	Ravindra Arya, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00735527 History of Changes
Other Study ID Numbers:	INLOR
Study First Received:	August 12, 2008
Last Updated:	May 4, 2009
Health Authority:	India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:

seizures
status epilepticus
lorazepam
intra-nasal

Additional relevant MeSH terms:

Seizures
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives

Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012