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

Study Overview
=================
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.

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

Conditions
-----------------
Investigate the Efficacy of Sucrose During Eye Examination

Intervention / Treatment
-----------------
* Dietary Supplement: Oral sucrose solution
* Dietary Supplement: Steril water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -VLBW infants <32 weeks of gestational age Exclusion Criteria: infants >32 weeks of gestational age neuromuscular abnormality major abnormality

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral sucrose solution<br>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 | Dietary Supplement: Steril water<br>* steril water plus topical anesthetics<br>|
| Placebo Comparator: steril water<br>steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given | Dietary Supplement: Oral sucrose solution<br>* Oral sucrose solution plus topical anesthetics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile | Premature Infant Pain Profile were determined after each eye examination | two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crying time | Crying time will be determined after each eye examination | two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eye examination, oral sucrose, premature infant pain scale