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

Phase 3
Completed
Conditions
Retinopathy of Prematurity
Interventions
Drug: Benoxinate Hydrochloride
Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
Registration Number
NCT06461975
Lead Sponsor
Alexandria University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
88
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Benoxinate HCL in first examBenoxinate Hydrochlorideinfants 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
Tear substitute in first examartificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.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.
Primary Outcome Measures
NameTimeMethod
PIPP score1-3 month after birth

The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Faculty of Medicine Alexandria University

🇪🇬

Alexandria, Egypt

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