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Sponsored by: |
University of Malawi College of Medicine |
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Information provided by: | University of Malawi College of Medicine |
ClinicalTrials.gov Identifier: | NCT00116064 |
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 |
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Status Epilepticus Convulsions |
Drug: intranasal lorazepam Drug: intramuscular paraldehyde |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children |
Estimated Enrollment: | 156 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 2 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
Paediatric Emergency Department, Queen Elizabeth Central Hospital | |
Blantyre, Malawi |
Study Director: | Elizabeth Molyneux, MRCPCH FFAEM | College of Medicine, University of Malawi |
Principal Investigator: | Shafique Ahmad, MRCPCH FFAEM | College of Medicine University of Malawi |
Study ID Numbers: | P03/04/248 |
Study First Received: | June 26, 2005 |
Last Updated: | July 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00116064 |
Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
intranasal lorazepam paediatric convulsions |
Status epilepticus Lorazepam Signs and Symptoms Epilepsy Status Epilepticus |
Seizures Neurologic Manifestations Central Nervous System Diseases Paraldehyde Brain Diseases |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |