Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions - Full Text View

Sponsor:	University of Malawi College of Medicine
Information provided by:	University of Malawi College of Medicine
ClinicalTrials.gov Identifier:	NCT00116064

Purpose

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.

Condition	Intervention	Phase
Status Epilepticus Convulsions	Drug: intranasal lorazepam Drug: intramuscular paraldehyde	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Paraldehyde Lorazepam

U.S. FDA Resources

Further study details as provided by University of Malawi College of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	156
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	2 Months to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116064

Locations

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

Sponsors and Collaborators

University of Malawi College of Medicine

Investigators

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

More Information

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.

ClinicalTrials.gov Identifier:	NCT00116064 History of Changes
Other Study ID Numbers:	P03/04/248
Study First Received:	June 26, 2005
Last Updated:	July 20, 2006
Health Authority:	Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Malawi College of Medicine:

intranasal
lorazepam
paediatric
convulsions

Additional relevant MeSH terms:

Seizures
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lorazepam
Paraldehyde
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012