Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06590870
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement INFENT PICC A Feasibility Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFENT PICC
Brief Summary:
The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants The primary goals are identifying whether enough infants join the study and complete the study procedures
Detailed Description:
Infants admitted to the neonatal intensive care unit NICU are subjected to multiple painful procedures as part of clinical care It is established that early and repeated exposure to pain is associated with negative consequences However pain management strategies continue to be underutilized in NICUs worldwide
Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access The procedure can cause moderate to severe pain To date the optimal medication for procedural analgesia during PICC placement is not known
Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU In preparation for a future definitive clinical trial this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement
Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access The procedure can cause moderate to severe pain To date the optimal medication for procedural analgesia during PICC placement is not known
Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU In preparation for a future definitive clinical trial this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement
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