Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children (INLOR)
Primary Purpose
Status Epilepticus, Seizures
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Lorazepam
Lorazepam
Sponsored by
About this trial
This is an interventional treatment trial for Status Epilepticus focused on measuring seizures, status epilepticus, lorazepam, intra-nasal
Eligibility 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
Sites / Locations
- All India Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
Outcomes
Primary Outcome Measures
Cessation of all clinical seizure activity within 10 min of drug administration
Secondary Outcome Measures
Persistent cessation of seizure activity for 1 hr
Patients requiring rescue medication within 1 hr
Time to achieve intra-venous access after arrival in casualty
Time from drug administration to termination of seizure(s)
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Development of significant respiratory depression requiring assisted ventilation
Full Information
NCT ID
NCT00735527
First Posted
August 12, 2008
Last Updated
May 4, 2009
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT00735527
Brief Title
Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Acronym
INLOR
Official Title
Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus, Seizures
Keywords
seizures, status epilepticus, lorazepam, intra-nasal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
Intra-venous 0.1 mg/kg (maximum 4 mg) once
Primary Outcome Measure Information:
Title
Cessation of all clinical seizure activity within 10 min of drug administration
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Persistent cessation of seizure activity for 1 hr
Time Frame
1 hr
Title
Patients requiring rescue medication within 1 hr
Time Frame
1 hr
Title
Time to achieve intra-venous access after arrival in casualty
Time Frame
minutes
Title
Time from drug administration to termination of seizure(s)
Time Frame
minutes
Title
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Time Frame
1 hr
Title
Development of significant respiratory depression requiring assisted ventilation
Time Frame
1 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
21275979
Citation
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. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.
Results Reference
derived
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Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
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