Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening. Participants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.

NCT Number	NCT07112430
Lead Sponsor	Marsha Campbell-Yeo Collaborators: Canadian Institutes of Health Research (CIHR), Dalhousie University, IWK Health Centre
Conditions	Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature, Fentanyl, Infant, Newborn, Neonatal Intensive Care Units, Analgesia +1 more
Enrollment	58 participants
Start Date	2026-09-09
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30