Evidence map›Paper›PMID 42458331›Full record

ArticleBMC pediatrics2026

Intranasal fentanyl to reduce pain intensity associated with retinopathy of prematurity screening in preterm infants: study protocol for a randomized controlled trial.

Helen McCord, Tim Disher, Véronique Promelle, Souvik Mitra, Balpreet Singh, Cameron Bruce, Carmen Peckham, Emily Neil, Marsha Campbell-Yeo

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07112430 (Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07112430 phase1 / phase2not yet recruitingnot on this map

Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial

TypeinterventionalSponsorMarsha Campbell-YeoRan2026 to 2028Enrolled58ConditionsNeonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, PrematureArmsFentanyl Citrate (Intranasal), Normal Saline (Placebo, Intranasal)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Helen McCordSchool of Nursing, Faculty of Health Dalhousie, Dalhousie University, 5869 University Avenue, PO Box 15000, Halifax, NS, Canada. hmccord@dal.ca.ORCID http://orcid.org/0009-0003-4002-1770
Tim DisherNeonatal Research, Research Services IWK Health, Sandpiper Analytics Halifax, 5850/5980 University Avenue Halifax, Halifax, NS, B3K 6R8, Canada.
Véronique PromellePediatric Ophthalmology and Strabismus, Department of Ophthalmology and Visual Sciences, IWK Health and Dalhousie University, 5850/5980 University Avenue Halifax, Halifax, NS, B3K 6R8, Canada.
Souvik MitraDepartment of Pediatrics, BC Children's Hospital, 4500 Oak Street, Vancouver, BC, V6H 3N1, Canada.
Balpreet SinghDepartment of Pediatrics, IWK Health, 3rd Floor, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada.
Cameron BruceMOM-LINC Lab, IWK Health, 8th Floor Children's Site 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada.
Carmen PeckhamIWK Health Parent Partner, Neonatal Intensive Care Unit (NICU), IWK Health, 3rd Floor, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada.
Emily NeilIWK Health Parent Partner, Neonatal Intensive Care Unit (NICU), IWK Health, 3rd Floor, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada.
Marsha Campbell-YeoSchool of Nursing, Faculty of Health Dalhousie, Dalhousie University, 5869 University Avenue, PO Box 15000, Halifax, NS, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreterm 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.

methodsThis 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 registrationClinicalTrials.gov, NCT07112430. https://clinicaltrials.gov/study/NCT07112430 Prospectively registered on August 8, 2025.

Indexed as

Analgesics, OpioidFentanylNeonatal ScreeningPain ManagementProcedural PainRetinopathy of PrematurityAdministration, IntranasalDouble-Blind MethodFemaleHumansInfant, NewbornInfant, PrematureMalePain MeasurementRandomized Controlled Trials as TopicAnalgesics, OpioidFentanylIntranasal fentanylNeonatal intensive care unitNeonatal painPreterm infantProcedural painRandomized controlled trialRetinopathy of prematurity

Identifiers

PMID42458331
PMCPMC13656511

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.