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Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
Sponsor: IWK Health Centre
Summary
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.
Official title: Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial
Key Details
Gender
All
Age Range
30 Weeks - 36 Weeks
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-10-01
Completion Date
2027-05-01
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
Interventions
Fentanyl Citrate (Intranasal)
Fentanyl citrate will be administered intranasally at a dose of 2 mcg/kg via a mucosal atomization device, 5 minutes prior to ROP screening. Used in conjunction with standard non-pharmacologic comfort strategies.
Normal Saline (Placebo, Intranasal)
An equivalent volume of intranasal normal saline will be administered using a mucosal atomization device, 5 minutes prior to ROP screening.