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

NCT ID: NCT01811979

Last Updated: 2013-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Investigate the Efficacy of Sucrose During Eye Examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Steril water

Intervention Type DIETARY_SUPPLEMENT

steril water plus topical anesthetics

steril water

steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given

Group Type PLACEBO_COMPARATOR

Oral sucrose solution

Intervention Type DIETARY_SUPPLEMENT

Oral sucrose solution plus topical anesthetics

Interventions

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Oral sucrose solution

Oral sucrose solution plus topical anesthetics

Intervention Type DIETARY_SUPPLEMENT

Steril water

steril water plus topical anesthetics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

-VLBW infants \<32 weeks of gestational age

Exclusion Criteria

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

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek Dilli

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eda Ç İlarslan, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Dr Sami Ulus Children Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23440783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24730361 (View on PubMed)

Related Links

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

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

Other Identifiers

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69/04.01.2012

Identifier Type: -

Identifier Source: org_study_id

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