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Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

NCT ID: NCT00343096

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective when given via the intranasal or buccal route as the intravenous route in terminating convulsions in children.

Detailed Description

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Convulsions are common in children. Prompt treatment with an effective anticonvulsant reduces longterm morbidity and mortality. The use of intravenous lorazepam as first line therapy in acute childhood convulsions where venous access has been obtained is widely accepted in developed countries. However, intravenous access can be a problem out of hospital or in small children.

Benzodiazepines such as Lorazepam have long been the mainstay of first line therapy for acute convulsions but there is insufficient clinical evidence as to the optimal mode of administration when venous access has failed. Lorazepam can be given via the intranasal and buccal route offering the potential to be as effective as intravenous lorazepam whilst being easier to administer and avoiding the need for intravenous cannulation.

To date there are no large published studies that have evaluated the efficacy and safety of intranasal or buccal lorazepam compared to intravenous lorazepam in the treatment of acute convulsions. In this study we wish to address the urgent need to obtain randomized controlled data in treating acute convulsions in children using a drug and delivery system that is safe, effective and easy to use in our setting.

Conditions

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Status Epilepticus Convulsions

Keywords

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intranasal buccal lorazepam paediatric convulsions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lorazepam

All doses 0.1mg/kg once, repeat after 10 minutes x1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

children with acute generalized seizures, continuing for a minimum of 5 minutes, who have not received any anti-convulsant therapy within 1 hour of presentation.

Exclusion Criteria

Children who have received anticonvulsant treatment within 1 hour prior to assessment. Any child whose seizures cease following correction of hypoglycaemia. Children with a known adverse reaction to lorazepam.
Minimum Eligible Age

2 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Molyneux

Professor of Paediatircs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Molyneux

Role: PRINCIPAL_INVESTIGATOR

College of Medicine

Locations

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Queen Elizabeth Central Hospital, Paediatric Dept, Box 360

Blantyre, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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The BIVIN Trial

Identifier Type: -

Identifier Source: org_study_id