Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity

Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01811979

Enrollment

Registered

2013-03-15

Start date

2012-04-30

Completion date

2013-05-31

Last updated

2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigate the Efficacy of Sucrose During Eye Examination

Keywords

eye examination, oral sucrose, premature infant pain scale

Brief summary

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Detailed description

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Interventions

DIETARY_SUPPLEMENTOral sucrose solution

Oral sucrose solution plus topical anesthetics

DIETARY_SUPPLEMENTSteril water

steril water plus topical anesthetics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Months

Healthy volunteers

Inclusion criteria

-VLBW infants \<32 weeks of gestational age

Exclusion criteria

* infants \>32 weeks of gestational age * neuromuscular abnormality * major abnormality

Design outcomes

Primary

Measure	Time frame	Description
Premature Infant Pain Profile	two hours	Premature Infant Pain Profile were determined after each eye examination

Secondary

Measure	Time frame	Description
Crying time	two hours	Crying time will be determined after each eye examination

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026