Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 9, 2013
May 1, 2013
1 year
March 13, 2013
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Premature Infant Pain Profile
Premature Infant Pain Profile were determined after each eye examination
two hours
Secondary Outcomes (1)
Crying time
two hours
Study Arms (2)
oral sucrose solution
ACTIVE COMPARATORlocal 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
PLACEBO COMPARATORsteril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given
Interventions
Eligibility Criteria
You may qualify if:
- VLBW infants \<32 weeks of gestational age
You may not qualify if:
- infants \>32 weeks of gestational age
- neuromuscular abnormality
- major abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Sami Ulus Children Hospital
Ankara, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 23440783BACKGROUNDDilli 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.
PMID: 24730361DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Eda Ç İlarslan, MD
MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
March 13, 2013
First Posted
March 15, 2013
Study Start
April 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
May 9, 2013
Record last verified: 2013-05