Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children (INLOR)

May 4, 2009 updated by: All India Institute of Medical Sciences, New Delhi

Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
Drug: Lorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Drug: Lorazepam
Intra-venous 0.1 mg/kg (maximum 4 mg) once
Active Comparator: 2
Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
Drug: Lorazepam
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
Drug: Lorazepam
Intra-venous 0.1 mg/kg (maximum 4 mg) once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cessation of all clinical seizure activity within 10 min of drug administration
Time Frame: 10 min
10 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Persistent cessation of seizure activity for 1 hr
Time Frame: 1 hr
1 hr
Patients requiring rescue medication within 1 hr
Time Frame: 1 hr
1 hr
Time to achieve intra-venous access after arrival in casualty
Time Frame: minutes
minutes
Time from drug administration to termination of seizure(s)
Time Frame: minutes
minutes
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Time Frame: 1 hr
1 hr
Development of significant respiratory depression requiring assisted ventilation
Time Frame: 1 hr
1 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INLOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Seizures

Clinical Trials on Lorazepam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe