Related Experiment Video
Updated: Jul 17, 2026
A Preterm Rat Model for Pain Studies
Published on: February 9, 2024
Intranasal fentanyl to reduce pain intensity associated with retinopathy of prematurity screening in preterm infants:
Helen McCord1,2, Tim Disher3, Véronique Promelle4
1School of Nursing, Faculty of Health Dalhousie, Dalhousie University, 5869 University Avenue, PO Box 15000, Halifax, NS, Canada. hmccord@dal.ca.
Insights
Intranasal fentanyl offers a promising solution for managing procedural pain in preterm infants undergoing retinopathy of prematurity screening. This study evaluates its effectiveness and safety, aiming to improve neonatal pain management strategies.
Area of Science:
- Neonatal Medicine
- Pain Management
- Ophthalmology
Background:
- Preterm infants experience significant pain during procedures like retinopathy of prematurity (ROP) screening.
- Current pain management strategies for ROP screening are often insufficient, leading to adverse neurodevelopmental outcomes.
- Intranasal fentanyl presents a potential alternative for rapid analgesia without IV access.
Purpose of the Study:
- To evaluate the effectiveness and safety of intranasal fentanyl for procedural pain relief in preterm infants during ROP screening.
- To address the gap in current neonatal pain management practices for ROP examinations.
Main Methods:
- A single-center, randomized, double-blind, placebo-controlled trial involving preterm infants (≤31 weeks GA or <1250g birth weight).
- Infants received either intranasal fentanyl (2 µg/kg) or placebo 10 minutes before ROP screening, alongside standard care.
- Pain intensity (PIPP-R), ongoing pain, recovery, cry duration, and physiological responses were primary and secondary outcomes.
Main Results:
- This section will report on the primary outcome of pain intensity (PIPP-R) during speculum insertion.
- Secondary outcomes including ongoing pain, recovery, cry duration, and physiological/salivary cortisol responses will be analyzed.
- Safety and tolerability of intranasal fentanyl will be assessed through adverse event monitoring.
Conclusions:
- This trial is expected to provide high-quality evidence on intranasal fentanyl's efficacy and safety for ROP screening pain.
- Results may inform clinical guidelines for improved pain management in preterm neonates.
- Findings could enhance the care of vulnerable preterm infants undergoing essential eye examinations.
Background:
Preterm infants are frequently exposed to painful procedures associated with adverse short- and long-term neurodevelopmental outcomes. Retinopathy of prematurity (ROP) screening is a necessary examination that is associated with moderate-to-high pain intensity scores and physiologic instability, despite the use of non-pharmacologic comfort measures and topical anesthesia. Current strategies have not reliably reduced procedural pain to mild or no pain levels, highlighting an important gap in neonatal pain management. Intranasal fentanyl provides rapid analgesia without requiring intravenous access and may offer a feasible option for procedural pain management in this population.
Methods:
This study is a single-center, randomized, double-blind, placebo-controlled trial conducted in a level III neonatal intensive care unit. Preterm infants born at ≤ 31 weeks' gestational age and/or with birth weight < 1250 g who are scheduled for clinically indicated ROP screening will be randomly assigned (1:1) to receive intranasal fentanyl (2 µg/kg) or intranasal normal saline placebo, administered 10 min prior to the examination, in addition to topical anesthesia and standard comfort measures. The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R) during the first 30 s following speculum insertion. Secondary outcomes include ongoing pain response, pain recovery, cry duration, physiologic recovery, salivary cortisol response, exam duration, adequacy of retinal visualization, and adverse events. Outcomes will be assessed using synchronized video, audio, and physiologic monitoring, with analyses conducted under an intention-to-treat framework.
Discussion:
This trial will provide high-quality evidence regarding the effectiveness and safety of intranasal fentanyl for procedural pain relief during ROP screening in preterm infants. Findings may inform future clinical guidelines and contribute to improved pain management practices for this population.
Trial Registration:
ClinicalTrials.gov, NCT07112430. https://clinicaltrials.gov/study/NCT07112430 Prospectively registered on August 8, 2025.