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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

This study has been completed.
Sponsor:
Information provided by:
University of Malawi College of Medicine
ClinicalTrials.gov Identifier:
NCT00116064
First received: June 26, 2005
Last updated: July 20, 2006
Last verified: June 2005
History of Changes
  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 3

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:

MedlinePlus related topics: Seizures
Drug Information available for: 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:

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 June 18, 2013