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Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Primary Purpose

Status Epilepticus, Convulsions

Status
Terminated
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
Lorazepam
Sponsored by
Kamuzu University of Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring intranasal, buccal, lorazepam, paediatric, convulsions

Eligibility Criteria

2 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Elizabeth Central Hospital, Paediatric Dept, Box 360

Outcomes

Primary Outcome Measures

Whether cessation of fit was achieved within ten minutes or not.

Secondary Outcome Measures

Frequency of additional drugs required to terminate presenting seizure
Frequency of cardio-respiratory side effects
Seizure recurrence within 24 hours of terminating the presenting seizure
Time from identification of a fitting child to cessation of fit.
Outcome of patients including any neurological sequelae at hospital discharge.

Full Information

First Posted
June 21, 2006
Last Updated
July 9, 2012
Sponsor
Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00343096
Brief Title
Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.
Official Title
Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
The buccal arm of the study was 30% less effective in stopping seizures within 10 minutes compared with the IV dose. This met a stopping rule for the study
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kamuzu University of Health Sciences

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus, Convulsions
Keywords
intranasal, buccal, lorazepam, paediatric, convulsions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
All doses 0.1mg/kg once, repeat after 10 minutes x1
Primary Outcome Measure Information:
Title
Whether cessation of fit was achieved within ten minutes or not.
Secondary Outcome Measure Information:
Title
Frequency of additional drugs required to terminate presenting seizure
Title
Frequency of cardio-respiratory side effects
Title
Seizure recurrence within 24 hours of terminating the presenting seizure
Title
Time from identification of a fitting child to cessation of fit.
Title
Outcome of patients including any neurological sequelae at hospital discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Molyneux
Organizational Affiliation
College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
City
Blantyre
ZIP/Postal Code
3
Country
Malawi

12. IPD Sharing Statement

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Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

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