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Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children (INLOR)
This study has been completed.
First Received: August 12, 2008   Last Updated: May 4, 2009   History of Changes
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
1: Experimental
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
Drug: Lorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
2: Active Comparator
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, Delhi
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

Responsible Party: All India Institute of Medical Sciences ( Ravindra Arya )
Study ID Numbers: INLOR
Study First Received: August 12, 2008
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00735527     History of Changes
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:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Brain Diseases
Lorazepam
Signs and Symptoms
Status Epilepticus
Therapeutic Uses
Hypnotics and Sedatives
Tranquilizing Agents
Nervous System Diseases
Seizures
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Diseases
Pharmacologic Actions
Epilepsy
Autonomic Agents
Neurologic Manifestations
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010