Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109395
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2005-04-27
Brief Title:
Lorazepam Sedation for Critically Ill Children
Sponsor:
The Emmes Company LLC
Organization:
The Emmes Company LLC
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This clinical trial is being performed under the Best Pharmaceuticals for Children Act signed into law in 2002 in order to improve pediatric labeling for off-patent drugs The purpose of this study is to make sure that lorazepam when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine is safe and works as well as a drug called midazolam Midazolam is already approved by the FDA for this use but lorazepam is not even though both drugs are commonly used for sedation
Detailed Description:
Lorazepam is used clinically for sedation of mechanically ventilated children but has not been approved by the FDA for this indication in children The purpose of this study in response to the Written Request by FDA is to determine the safety efficacy and dosage required for lorazepam compared with midazolam which is approved by FDA for children for this indication
Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation Participants will be randomized to lorazepam intermittent bolus or continuous infusion or midazolam continuous infusion Sedation will be monitored using the COMFORT score Blood will be drawn to measure lorazepammidazolam plasma concentrations and to measure the plasma concentrations of excipients benzyl alcohol and glycols in patients receiving lorazepam
Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation Participants will be randomized to lorazepam intermittent bolus or continuous infusion or midazolam continuous infusion Sedation will be monitored using the COMFORT score Blood will be drawn to measure lorazepammidazolam plasma concentrations and to measure the plasma concentrations of excipients benzyl alcohol and glycols in patients receiving lorazepam
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