Speculum-free retinopathy of prematurity screening with a proparacaine-soaked cotton-swab: A randomized controlled trial in preterm infants

Abstract

Background: Retinopathy of prematurity (ROP) is a major cause of blindness in premature babies, and screening can be stressful and painful for infants. This study investigates the efficacy of a novel method of scleral indentation involving a local anesthetic-impregnated cotton swab without the use of an eyelid speculum to reduce pain and stress in premature infants during ROP screening.

Methods: This prospective, single-center, parallel-group, randomized controlled study was conducted between July 2024 and February 2025 at Harran University Faculty of Medicine, Ophthalmology Outpatient Clinic. Two hundred premature newborns requiring ROP screening were randomized into 2 equal groups: a new technique group (Group 1) and a standard screening group (Group 2). In the intervention group, the eyelids were gently opened manually, and scleral indentation was performed using a cotton swab soaked in 0.5% proparacaine, which served both as a depressor and a comfort aid during binocular indirect ophthalmoscopy. Pain and stress responses were assessed using the premature infant pain profile-revised.

Results: Mean total premature infant pain profile-revised scores during the screening examination were significantly lower in Group 1 (6.99 ± 1.81) than in Group 2 (9.44 ± 2.63) (P < .001). Similarly, mean total scores 1 minute after the examination were significantly lower in Group 1 (1.92 ± 1.15) than in Group 2 (3.45 ± 1.82) (P < .001). The mean duration of crying during the screening examination was significantly shorter in Group 1 (51.4 ± 7.22 seconds) compared to Group 2 (56.5 ± 12.2 seconds) (P < .001). Mean heart rates during scanning were significantly lower in Group 1 (167 ± 22.8 bpm) than in Group 2 (186 ± 19.3 bpm) (P < .001), and this difference persisted after 5 minutes (P = .001). Multivariate linear regression analysis demonstrated that the intervention group experienced significantly lower total scores during the examination, shorter crying duration, and reduced heart rate, compared to the control group.

Conclusion: The new ROP screening method is associated with less pain and stress in premature infants compared to the standard method. This new approach could be an important alternative to make ROP screening more comfortable for infants.

Keywords: innovative ophthalmology; neonatal pain reduction; premature infant care; retinopathy of prematurity; retinopathy prevention.