NCT00116064

Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (planned)
• Sponsor: Kamuzu University of Health Sciences · Academic / Other
• Sex: All
• Age: 2 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Status Epilepticus
• Convulsions

Interventions

Type	Name	Description
DRUG	intranasal lorazepam
DRUG	intramuscular paraldehyde

Timeline

• Start date: 2004-07-01
• Completion: 2005-06-01
• First posted: 2005-06-27
• Last updated: 2006-07-21

Locations

1 site across 1 country: Malawi