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Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Information source: All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus; Seizures

Intervention: Lorazepam (Drug); Lorazepam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: All India Institute of Medical Sciences, New Delhi

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cessation of all clinical seizure activity within 10 min of drug administration

Secondary outcome:

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

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 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

Locations and Contacts

All India Institute of Medical Sciences, New Delhi, Delhi 110029, India
Additional Information

Starting date: May 2008
Last updated: May 4, 2009

Page last updated: August 23, 2015

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