Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Phase 3

Completed

• Conditions: Status Epilepticus; Convulsions

• Registration Number: NCT00116064
• Lead Sponsor: Kamuzu University of Health Sciences

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.

Study Timeline

• Study Start: 2004-07
• Status Verified: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-06-26
• Study First Submitted QC: 2005-06-26
• Study First Posted: 2005-06-27
• Last Update Submitted: 2006-07-20
• Last Update Posted: 2006-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Children aged between 2 months and 12 years
• Presenting with generalised convulsions

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
seizure recurrence within 24 hours of cessation of presenting convulsion
survival/death
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

Trial Locations

Locations (1)

Paediatric Emergency Department, Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi