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.
Preterm infants born ≤31 weeks gestational age and/or with birth weight <1250 g
Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care
Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support
Written informed consent obtained from a parent or legally authorized representative
Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration
Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative/analgesic medications within 24 hours prior to the ROP examination
Known hypersensitivity or prior adverse reaction to fentanyl
Parallel
Fentanyl Citrate (Intranasal)
DrugFentanyl citrate will be administered intranasally at a dose of 2 mcg/kg via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. The intervention will be delivered 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.
Normal Saline (Placebo, Intranasal)
DrugAn equivalent volume of intranasal 0.9% normal saline placebo will be administered via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. 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.
Pain intensity during ROP screening
Pain intensity will be measured using the Premature Infant Pain Profile-Revised (PIPP-R). The primary endpoint is the PIPP-R score during the first 30 seconds following speculum insertion during the ROP examination.
Proportion of infants with low to mild pain
The proportion of infants experiencing low or mild pain will be determined using PIPP-R score thresholds (≤6), assessed by blinded coders from synchronized video recordings during and following the ROP examination.
Ongoing pain response during ROP screening
Pain response will be assessed using PIPP-R scores measured at 30-second intervals from speculum insertion until completion of the ROP examination, coded from synchronized video by blinded assessors.
Pain recovery following ROP screening
Pain recovery will be evaluated using PIPP-R scores measured at 1 and 5 minutes following completion of the ROP examination to assess resolution of pain.
Cry duration
Total cry duration (in seconds) will be measured from synchronized video recordings during the ROP examination and recovery period by trained, blinded assessors.
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Marsha Campbell-Yeo
Lead sponsor
IWK Health Centre
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
Dalhousie University
Collaborator
IWK Health Centre
Collaborator
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