Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Inclusion Criteria:

• Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
• Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
• Infants were believed to require at least 2 ROP screenings

Exclusion Criteria:

• Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
• Infants who required mechanical ventilation or continuous positive airway pressure at the first examination

Data are available and owned by the authors and can be shared upon request

A dedicated clinical pharmacist placed the topical benoxinate HCL (Benox ®, Removed for facilitating the blinded review). and the artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops (Polyfresh ®, Removed for facilitating the blinded review) in identical bottles, each of them had a code that was changed every clinic and was not known to the examining ophthalmologist, the nurse in charge of swaddling the baby and putting the drops or the attending neonatologist monitoring the infant and recording the PIPP score. The clinical pharmacist would ensure that crossover was performed in the second examination of every study child.