Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Study Overview
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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.

Official Title
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A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

Conditions
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Status Epilepticus, Convulsions

Intervention / Treatment
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* Drug: intranasal lorazepam
* Drug: intramuscular paraldehyde


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intranasal lorazepam|nan|
|Drug: intramuscular paraldehyde|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal, lorazepam, paediatric, convulsions