Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391105
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2006-10-19
Brief Title:
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome RDS
Status:
COMPLETED
Status Verified Date:
2006-10
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:
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil n10 and morphine n10 in mechanically ventilated premature neonates 28-34wk regarding the time to be awake and the time until extubation after interruption of the opioid administration
Detailed Description:
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome RDS and is associated with physiologic biochemical and clinical responses indicating pain and stress in prematures Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures Unlike morphine remifentanil has an unique pharmacokinetic properties with a rapid onset of action and a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 32 minutes So it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids
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