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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Primary Purpose

Status Epilepticus, Convulsions

Status
Completed
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
intranasal lorazepam
intramuscular paraldehyde
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, lorazepam, paediatric, convulsions

Eligibility Criteria

2 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children aged between 2 months and 12 years Presenting with generalised convulsions Exclusion Criteria: Any child who had received an anticonvulsant agent within 1 hour of presentation Seizure stopped with rapid cooling or treatment of hypoglycaemia Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy

Sites / Locations

  • Paediatric Emergency Department, Queen Elizabeth Central Hospital

Outcomes

Primary Outcome Measures

whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Secondary Outcome Measures

time from drug administration to cessation of convulsion
frequency of episodes requiring 2 or more anticonvulsant agents
continuous blood pressure and oxygen saturation for 30 minutes post drug administration
seizure recurrence within 24 hours of cessation of presenting convulsion
survival/death

Full Information

First Posted
June 26, 2005
Last Updated
July 20, 2006
Sponsor
Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00116064
Brief Title
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
Official Title
A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kamuzu University of Health Sciences

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
Detailed Description
The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intranasal lorazepam
Intervention Type
Drug
Intervention Name(s)
intramuscular paraldehyde
Primary Outcome Measure Information:
Title
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
Secondary Outcome Measure Information:
Title
time from drug administration to cessation of convulsion
Title
frequency of episodes requiring 2 or more anticonvulsant agents
Title
continuous blood pressure and oxygen saturation for 30 minutes post drug administration
Title
seizure recurrence within 24 hours of cessation of presenting convulsion
Title
survival/death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged between 2 months and 12 years Presenting with generalised convulsions Exclusion Criteria: Any child who had received an anticonvulsant agent within 1 hour of presentation Seizure stopped with rapid cooling or treatment of hypoglycaemia Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Molyneux, MRCPCH FFAEM
Organizational Affiliation
Kamuzu University of Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shafique Ahmad, MRCPCH FFAEM
Organizational Affiliation
Kamuzu University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paediatric Emergency Department, Queen Elizabeth Central Hospital
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
16698412
Citation
Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7. doi: 10.1016/S0140-6736(06)68696-0.
Results Reference
result

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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

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