Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Information source: All India Institute of Medical Sciences, New Delhi
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Status Epilepticus; Seizures
Intervention: Lorazepam (Drug); Lorazepam (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: All India Institute of Medical Sciences, New Delhi Overall contact:
Ravindra Arya, M.D., Phone: 919717578673, Email: ravindra.arya4@gmail.com
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.
Clinical Details
Official title: Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Cessation of all clinical seizure activity within 10 min of drug administration
Secondary outcome: Persistent cessation of seizure activity for 1 hrPatients 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
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children presenting convulsing to the pediatric emergency or developing seizure while
in casualty
- Age 6-14 yrs
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
Locations and Contacts
Ravindra Arya, M.D., Phone: 919717578673, Email: ravindra.arya4@gmail.com
All India Institute of Medical Sciences, New Delhi, Delhi 110029, India; Recruiting
Ravindra Arya, M.D., Principal Investigator
Madhulika Kabra, M.D., Sub-Investigator
Additional Information
Starting date: May 2008
Ending date: April 2009
Last updated: August 14, 2008
|
