Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

Summary

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.

Timeline

Start

2026-09-09

Primary completion

2028-03-01

Completion

2028-06-01

Publications

• McCord H, Disher T, Promelle V, Mitra S, Singh B, Bruce C, Peckham C, Neil E, Campbell-Yeo M. Intranasal fentanyl to reduce pain intensity associated with retinopathy of prematurity screening in preterm infants: study protocol for a randomized controlled trial. BMC Pediatr. 2026 Jul 15. doi: 10.1186/s12887-026-07328-x. Online ahead of print.

Drugs

Indications