Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A...

Area of Science:

• Neonatalogy
• Pharmacology
• Clinical Trials

Background:

• Preterm infants in the NICU undergo painful procedures, such as peripherally inserted central catheter (PICC) placement.
• Current pharmacological interventions for procedural pain are inconsistently used due to adverse event concerns.
• Intranasal (IN) fentanyl offers rapid, targeted analgesia, presenting a potential alternative.

Purpose of the Study:

• To assess the feasibility of a definitive randomized controlled trial (RCT) for IN fentanyl in preterm infants undergoing PICC placement.
• To evaluate the acceptability and adoption of IN fentanyl for procedural pain management in the NICU.

Main Methods:

• A blinded RCT randomized preterm infants (<32 weeks GA) undergoing their first PICC to IN fentanyl or placebo, alongside standard care.
• Primary feasibility outcomes included recruitment rates and pain assessment data completeness.
• Secondary outcomes assessed adverse events and healthcare provider acceptability and adoption of IN fentanyl.

Main Results:

• Recruitment fell short of the target (8/16 approached, 50% consent rate), preventing the enrollment of 24 participants.
• All video recordings (100%) were suitable for pain assessment, meeting the data completeness target.
• No adverse events were reported; healthcare providers found IN fentanyl acceptable but faced adoption barriers.

Conclusions:

• Significant modifications to recruitment strategies are necessary to conduct a definitive RCT.
• Further strategies are needed to facilitate the clinical adoption of IN fentanyl for procedural analgesia in the NICU.