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| Sponsor: | University of Malawi College of Medicine |
|---|---|
| Information provided by: | University of Malawi College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00343096 |
Purpose
This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective when given via the intranasal or buccal route as the intravenous route in terminating convulsions in children.
| Condition | Intervention |
|---|---|
|
Status Epilepticus Convulsions |
Drug: Mode of administration - buccal, intranasal or intravenous |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Buccal, Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre, Malawi: a Randomized Trial |
| Estimated Enrollment: | 1200 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Convulsions are common in children. Prompt treatment with an effective anticonvulsant reduces longterm morbidity and mortality. The use of intravenous lorazepam as first line therapy in acute childhood convulsions where venous access has been obtained is widely accepted in developed countries. However, intravenous access can be a problem out of hospital or in small children.
Benzodiazepines such as Lorazepam have long been the mainstay of first line therapy for acute convulsions but there is insufficient clinical evidence as to the optimal mode of administration when venous access has failed. Lorazepam can be given via the intranasal and buccal route offering the potential to be as effective as intravenous lorazepam whilst being easier to administer and avoiding the need for intravenous cannulation.
To date there are no large published studies that have evaluated the efficacy and safety of intranasal or buccal lorazepam compared to intravenous lorazepam in the treatment of acute convulsions. In this study we wish to address the urgent need to obtain randomized controlled data in treating acute convulsions in children using a drug and delivery system that is safe, effective and easy to use in our setting.
Eligibility| Ages Eligible for Study: | 2 Months to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
children with acute generalized seizures, continuing for a minimum of 5 minutes, who have not received any anti-convulsant therapy within 1 hour of presentation.
Exclusion Criteria:
Children who have received anticonvulsant treatment within 1 hour prior to assessment. Any child whose seizures cease following correction of hypoglycaemia. Children with a known adverse reaction to lorazepam.
Contacts and Locations| Malawi | |
| Queen Elizabeth Central Hospital, Paediatric Dept, Box 360 | |
| Blantyre, Malawi, 3 | |
| Principal Investigator: | Elizabeth Molyneux | College of Medicine |
More Information
| Responsible Party: | Prof E Molyneux, College of Medicine, Malawi |
| ClinicalTrials.gov Identifier: | NCT00343096 History of Changes |
| Other Study ID Numbers: | The BIVIN Trial |
| Study First Received: | June 21, 2006 |
| Last Updated: | March 12, 2008 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
|
intranasal buccal lorazepam paediatric convulsions |
|
Seizures Status Epilepticus Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Lorazepam 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 |