| CTRI Number |
CTRI/2008/091/000135 [Registered on: 03/11/2008] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nasal vs. venous lorazepam for control of acute seizures in children |
|
Scientific Title of Study
|
Intra-nasal vs. intra-venous lorazepam for control of acute seizures in children: Prospective open labeled randomized equivalence trial |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00735527 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravindra Arya |
| Designation |
|
| Affiliation |
|
| Address |
Division of Pediatric Neurology, Dept of Pediatrics
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09717578673 |
| Fax |
|
| Email |
ravindra.arya4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravindra Arya |
| Designation |
|
| Affiliation |
|
| Address |
Division of Pediatric Neurology, Dept of Pediatrics
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09717578673 |
| Fax |
|
| Email |
ravindra.arya4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravindra Arya |
| Designation |
|
| Affiliation |
|
| Address |
Division of Pediatric Neurology, Dept of Pediatrics
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09717578673 |
| Fax |
|
| Email |
ravindra.arya4@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar, New Delhi |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences
Ansari Nagar, New Delhi |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravindra Arya |
All India Institute of Medical Sciences |
Ansari Nagar,-110029
New Delhi
DELHI |
09717578673
ravindra.arya4@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Status epilepticus
acute seizures , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra nasal lorazepam |
0.1 mg/kg once |
| Comparator Agent |
intravenous lorazepam |
0.1 mg/kg once |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
Age 6-14 yrs
|
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| ExclusionCriteria |
| Details |
Known hypersensitivity to any benzodiazepine
Child has received any parenteral anti-convulsant within 1 hr prior to enrolment
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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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Cessation of all clinical seizure activity within 10 min of drug administration |
10 min |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Persistent cessation of seizure activity for 1 hr |
1 hour |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/06/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Status epilepticus (SE) is a common pediatric emergency which requires rapid termination of seizures. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam, administered by intravenous (IV) route is the standard of care as first line therapy for control of seizures in SE. We intend to compare efficacy and adverse effect profile of intranasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for venous cannulation is not available. Alternate route of administration (intranasal) if shown equivalent to conventional IV route, will be very useful for management of seizures in children in emergency room, in patient or out of hospital settings. |