Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity

Treatments: Drug: Benoxinate Hydrochloride; Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.

Study type: Interventional

Funder types: Other

Identifiers

NCT06461975

Benoxinate drops for ROP exam

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 28 to 90 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Tear substitute in first exam

Experimental group

Description:

Te first examination was done using the tear substitute eye drops and the second using the Benoxinate HCL drops given just before the ROP screening.

Treatment:

Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.

Benoxinate HCL in first exam

Experimental group

Description:

infants in Group B had the reversed order of the drops in the two examinations. the first examination done using the Benoxinate HCL drops and the second using the tear substitute eye drops

Treatment:

Drug: Benoxinate Hydrochloride