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

This study has been completed.
Sponsor:
Information provided by:
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
History of Changes
  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 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:

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):

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 May 21, 2013