Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343096
Status:
TERMINATED
Last Update Posted:
2012-07-10
First Post:
2006-06-21
Brief Title:
Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children
Sponsor:
Kamuzu University of Health Sciences
Organization:
Kamuzu University of Health Sciences
Study Overview
Official Title:
Buccal Intranasal or Intravenous Lorazepam for the Treatment of Acute Convulsions in Children in Blantyre Malawi a Randomized Trial
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The buccal arm of the study was 30 less effective in stopping seizures within 10 minutes compared with the IV dose This met a stopping rule for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None