Intranasal Fentanyl for Pain Management in Retinopathy of Prematurity
(FIREFLY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for premature infants born before 32 weeks who are about to have their first eye exam for retinopathy of prematurity (ROP). Babies must be clinically stable, and parents or guardians need to give consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Fentanyl Citrate (Intranasal)
Trial Overview
Researchers are testing if a nasal spray form of fentanyl can safely reduce pain during routine ROP eye exams in preterm babies. Infants will randomly receive either fentanyl or a placebo spray, along with usual comfort care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in this group will receive intranasal fentanyl at a dose of 2 mcg/kg administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening. The study drug will be delivered via a mucosal atomization device into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.
Participants in this group will receive an equivalent volume of intranasal 0.9% normal saline placebo administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening using a mucosal atomization device. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marsha Campbell-Yeo
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Dalhousie University
Collaborator
IWK Health Centre
Collaborator
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