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

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.

Study Overview

• Status: Completed
• Conditions: Investigate the Efficacy of Sucrose During Eye Examination
• Intervention / Treatment: Dietary supplement: Steril water; Dietary supplement: Oral sucrose solution

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Dr Sami Ulus Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-VLBW infants <32 weeks of gestational age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oral sucrose solution; 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; steril water plus topical anesthetics
Placebo Comparator: steril water; steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given	Dietary supplement: Oral sucrose solution; Oral sucrose solution plus topical anesthetics

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

Collaborators and Investigators

• Sponsor: Dr. Sami Ulus Children's Hospital
• Investigators: Principal Investigator: Eda Ç İlarslan, MD, MD

Publications and helpful links

General Publications

• Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4.
• Dilli D, Ilarslan NE, Kabatas EU, Zenciroglu A, Simsek Y, Okumus N. Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatr. 2014 Feb;103(2):e76-9. doi: 10.1111/apa.12454. Epub 2013 Nov 11.

Helpful Links

• http://www.ncbi.nlm.nih.gov/pubmed/23440783

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 9, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: eye examination, oral sucrose, premature infant pain scale
• Other Study ID Numbers: 69/04.01.2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No