This single-center, double-blinded, randomized controlled trial aims to evaluate the efficacy and safety of intranasal fentanyl (INF) for reducing pain during retinopathy of prematurity (ROP) screening in preterm infants. The trial will enroll preterm neonates (≤32 weeks gestation) requiring ROP screening and randomize them to receive either intranasal fentanyl (2 mcg/kg) or a placebo (normal saline) 5-10 minutes prior to the procedure. The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R) at 30 seconds after speculum insertion. Secondary outcomes include physiological (heart rate, oxygen saturation), behavioral (crying time), and recovery indicators, along with adverse events and need for rescue dosing. This study addresses a critical gap in evidence by exploring a non-invasive pharmacologic intervention for procedural pain in the neonatal intensive care unit (NICU) setting. The findings may inform future practice and guidelines for neonatal pain management.
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Pain intensity during ROP screening
Timeframe: 30 seconds after speculum insertion during ROP screening
Helen McCord, BScN, MN, PhD Candidate, NNP