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

This study has been completed.
Information provided by:
All India Institute of Medical Sciences, New Delhi Identifier:
First received: August 12, 2008
Last updated: May 4, 2009
Last verified: May 2009
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
Drug: Lorazepam
Phase 3

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:

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


Ages Eligible for Study:   6 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00735527

All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ravindra Arya, All India Institute of Medical Sciences 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:
status epilepticus

Additional relevant MeSH terms:
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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 processed this record on December 02, 2016