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.

Conditions

• Neonatal Pain
• Retinopathy of Prematurity (ROP)
• Pain Management
• Infant, Premature
• Fentanyl
• Infant, Newborn
• Neonatal Intensive Care Units
• Analgesia
• Intranasal Drug Administration

Interventions

DRUG

Fentanyl Citrate (Intranasal)

Fentanyl 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.

DRUG

Normal Saline (Placebo, Intranasal)

An 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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Dalhousie University

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Marsha Campbell-Yeo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-09

Primary Completion

2028-03-01

Completion

2028-06-01

Countries

• Canada

Study Locations