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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

NCT ID: NCT00116064

Last Updated: 2006-07-21

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Status Epilepticus Convulsions

Keywords

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intranasal lorazepam paediatric convulsions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intranasal lorazepam

Intervention Type DRUG

intramuscular paraldehyde

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Elizabeth Molyneux, MRCPCH FFAEM

Role: STUDY_DIRECTOR

Kamuzu University of Health Sciences

Shafique Ahmad, MRCPCH FFAEM

Role: PRINCIPAL_INVESTIGATOR

Kamuzu University of Health Sciences

Locations

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Paediatric Emergency Department, Queen Elizabeth Central Hospital

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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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.

Reference Type RESULT
PMID: 16698412 (View on PubMed)

Other Identifiers

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P03/04/248

Identifier Type: -

Identifier Source: org_study_id