NCT06590870

Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): a Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Procedural Pain

Interventions

Type	Name	Description
DRUG	Fentanyl	The fentanyl solution for administration will be prepared by diluting 2 mL of fentanyl 50 µg/mL with 8 mL of normal saline (bacteriostatic 0.9% sodium chloride) for a fentanyl solution of 10 µg/mL.
DRUG	Normal saline	The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-02-09
• Completion: 2025-02-09
• First posted: 2024-09-19
• Last updated: 2025-02-20

Locations

1 site across 1 country: Canada