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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

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ClinicalTrials.gov Identifier: NCT00116064
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : July 21, 2006
Sponsor:
Information provided by:
University of Malawi College of Medicine

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.

Condition or disease Intervention/treatment Phase
Status Epilepticus Convulsions Drug: intranasal lorazepam Drug: intramuscular paraldehyde Phase 3

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  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2004
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam
U.S. FDA Resources




Primary Outcome Measures :
  1. whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Secondary Outcome Measures :
  1. time from drug administration to cessation of convulsion
  2. frequency of episodes requiring 2 or more anticonvulsant agents
  3. continuous blood pressure and oxygen saturation for 30 minutes post drug administration
  4. seizure recurrence within 24 hours of cessation of presenting convulsion
  5. survival/death


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00116064     History of Changes
Other Study ID Numbers: P03/04/248
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: July 21, 2006
Last Verified: June 2005

Keywords provided by University of Malawi College of Medicine:
intranasal
lorazepam
paediatric
convulsions

Additional relevant MeSH terms:
Status Epilepticus
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lorazepam
Paraldehyde
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action