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

Not Applicable

Completed

• Conditions: Investigate the Efficacy of Sucrose During Eye Examination
• Interventions: Dietary Supplement: Steril water; Dietary Supplement: Oral sucrose solution

• Registration Number: NCT01811979
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Primary Completion: 2013-04
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-VLBW infants <32 weeks of gestational age

Exclusion Criteria

• infants >32 weeks of gestational age
• neuromuscular abnormality
• major abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral sucrose solution	Steril water	local anesthetic eye drops (Alcaine 0.5% drop) and a pacifier, plus 0.5 cc/kg of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity will be given
steril water	Oral sucrose solution	steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile	two hours	Premature Infant Pain Profile were determined after each eye examination

Secondary Outcome Measures

Name	Time	Method
Crying time	two hours	Crying time will be determined after each eye examination

Trial Locations

Locations (1)

Dr Sami Ulus Children Hospital; 🇹🇷 Ankara, Turkey