Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116064
Status:
COMPLETED
Last Update Posted:
2006-07-21
First Post:
2005-06-26
Brief Title:
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
Sponsor:
Kamuzu University of Health Sciences
Organization:
Kamuzu University of Health Sciences
Study Overview
Official Title:
A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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