Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

NCT07112430 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IWK_INF_PainTrial2025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

intranasal fentanyl; fentanyl; neonatal analgesia; procedural pain; ROP screening; Retinopathy of Prematurity; Preterm infants; Premature infants; infant pain; Non-invasive analgesia; Opioid analgesia; Intranasal drug delivery; Neonatal intensive care; NICU; Pain management in neonates; Infant procedural sedation

Outcome Measures

Primary Outcomes (1)

• Pain intensity during ROP screening

  Pain intensity will be measured using the Premature Infant Pain Profile-Revised (PIPP-R) score. The score will be assessed 30 seconds after insertion of the speculum, during the ROP eye examination.

  30 seconds after speculum insertion during ROP screening

Secondary Outcomes (11)

• Proportion of infants with low to mild pain

  30 seconds after speculum insertion

• Pain response during ROP screening

  Every 30 seconds throughout the procedure

• Pain recovery following ROP screening

  End of procedure, 1-minute and 5-minutes post-procedure

• Cry time during and after procedure

  During and after the ROP screening procedure

• Salivary cortisol levels

  Pre-procedure and 20 minutes post-procedure

Study Arms (2)

Intranasal Fentanyl Group

EXPERIMENTAL

Participants in this group will receive intranasal fentanyl at a dose of 2 mcg/kg administered 5 minutes prior to initiation of retinopathy of prematurity (ROP) screening. Fentanyl will be delivered via a mucosal atomization device in conjunction with standard non-pharmacologic comfort measures.

Drug: Fentanyl Citrate (Intranasal)

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an equivalent volume of intranasal normal saline (placebo) administered 5 minutes prior to ROP screening using a mucosal atomization device. Standard non-pharmacologic comfort measures will also be provided.

Drug: Normal Saline (Placebo, Intranasal)

Interventions

Fentanyl Citrate (Intranasal) DRUG

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.

Intranasal Fentanyl Group

Normal Saline (Placebo, Intranasal) DRUG

An equivalent volume of intranasal normal saline will be administered using a mucosal atomization device, 5 minutes prior to ROP screening.

Placebo Group

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at \<32 weeks gestational age
• Undergoing their first screening for retinopathy of prematurity (ROP)
• Clinically stable at the time of the procedure
• Parental or legal guardian informed consent obtained

You may not qualify if:

• Known or suspected congenital anomalies affecting the nose
• Receipt of systemic analgesics or sedatives at the time of ROP screening
• Nasal obstruction or malformations that interfere with intranasal drug delivery
• Contraindications to fentanyl (e.g., known hypersensitivity)

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Retinopathy of Prematurity; Agnosia; Premature Birth; Pain, Procedural

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Helen McCord, BScN, MN, PhD Candidate, NNP

CONTACT

19024971412; mccordhelen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a quadruple-masked (participant, care provider, investigator, and outcome assessor) randomized controlled trial. Blinding is maintained through the use of identical-appearing administration devices for the study drug and placebo. The clinical team, including those administering the intervention and assessing outcomes such as PIPP-R scores, are unaware of group allocation to reduce bias. Allocation concealment is ensured via centralized randomization and pharmacy-controlled preparation of interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group trial. Eligible preterm infants undergoing their first retinopathy of prematurity (ROP) screening will be randomly assigned to receive either intranasal fentanyl or a placebo (normal saline) prior to the procedure. Each participant will remain in their assigned group for the duration of the intervention. The primary aim is to evaluate the analgesic effectiveness and safety of intranasal fentanyl compared to placebo.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-06