Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Status Epilepticus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116064
• Other study ID #: P03/04/248
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2005
• Last updated: July 20, 2006
• Start date: July 2004
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: University of Malawi College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Convulsions
• Seizures
• Status Epilepticus

Intervention

Drug:
• intranasal lorazepam

• intramuscular paraldehyde

Locations

Country	Name	City	State
Malawi	Paediatric Emergency Department, Queen Elizabeth Central Hospital	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
Secondary	time from drug administration to cessation of convulsion
Secondary	frequency of episodes requiring 2 or more anticonvulsant agents
Secondary	continuous blood pressure and oxygen saturation for 30 minutes post drug administration
Secondary	seizure recurrence within 24 hours of cessation of presenting convulsion
Secondary	survival/death