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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735527
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : May 5, 2009
Information provided by:
All India Institute of Medical Sciences, New Delhi

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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Lorazepam

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

Primary Outcome Measures :
  1. Cessation of all clinical seizure activity within 10 min of drug administration [ Time Frame: 10 min ]

Secondary Outcome Measures :
  1. Persistent cessation of seizure activity for 1 hr [ Time Frame: 1 hr ]
  2. Patients requiring rescue medication within 1 hr [ Time Frame: 1 hr ]
  3. Time to achieve intra-venous access after arrival in casualty [ Time Frame: minutes ]
  4. Time from drug administration to termination of seizure(s) [ Time Frame: minutes ]
  5. Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration [ Time Frame: 1 hr ]
  6. Development of significant respiratory depression requiring assisted ventilation [ Time Frame: 1 hr ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00735527

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All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ravindra Arya, All India Institute of Medical Sciences Identifier: NCT00735527    
Other Study ID Numbers: INLOR
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009
Keywords provided by All India Institute of Medical Sciences, New Delhi:
status epilepticus
Additional relevant MeSH terms:
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Status Epilepticus
Neurologic Manifestations
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action