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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
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.
The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.
Mount Sinai Hospital
Toronto, Ontario, Canada
Recruitment rate
Number of infants assessed for eligibility, number of infants approached for consent, number of enrolled infants, and number of participants completing study procedures
Time frame: 6 month study period
Completeness of data collection for pain score assessment
Premature infant pain profile-revised (PIPP-R) scores using video recordings. PIPP-R scores range from 0-21 and are interpreted as no pain (score of 0), mild pain (score 1-6), moderate pain (score 7-12), and severe pain (score 13-21).
Time frame: At the needle insertion phase of the PICC placement
Number of adverse events
Number of apneas (cessation of breathing \> 20 seconds), number of bradycardias (heart rate \< 100 beats per minute), number of desaturations (oxygen saturation \< 80%), chest wall rigidity, escalation in ventilatory support, and need for other analgesia
Time frame: Up to 6 hours after intranasal intervention administration
Acceptability and adoption of intranasal medications
Survey of healthcare team members capturing experience with intranasal intervention administration, including barriers and enablers to use intranasal medications
Time frame: Immediately after the PICC placement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.