Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions - Tabular View

Tracking Information

First Received Date ^ICMJE

June 26, 2005

Last Updated Date

July 20, 2006

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00116064 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Status Epilepticus
Convulsions

Intervention ^ICMJE

Drug: intranasal lorazepam
Drug: intramuscular paraldehyde

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

156

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Malawi

Administrative Information

NCT ID ^ICMJE

NCT00116064

Responsible Party

Study ID Numbers ^ICMJE

P03/04/248

Study Sponsor ^ICMJE

University of Malawi College of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Elizabeth Molyneux, MRCPCH FFAEM	College of Medicine, University of Malawi
Principal Investigator:	Shafique Ahmad, MRCPCH FFAEM	College of Medicine University of Malawi

Information Provided By

University of Malawi College of Medicine

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP