Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

July 20, 2006 updated by: Kamuzu University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Paediatric Emergency Department, Queen Elizabeth Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamuzu University of Health Sciences

Investigators

  • Study Director: Elizabeth Molyneux, MRCPCH FFAEM, Kamuzu University of Health Sciences
  • Principal Investigator: Shafique Ahmad, MRCPCH FFAEM, Kamuzu University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria

June 26, 2005

First Posted (Estimate)

June 27, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2006

Last Update Submitted That Met QC Criteria

July 20, 2006

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03/04/248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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