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Clinical Trials/NCT01811979
NCT01811979
Completed
Not Applicable

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

Dr. Sami Ulus Children's Hospital1 site in 1 country60 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Investigate the Efficacy of Sucrose During Eye Examination
Sponsor
Dr. Sami Ulus Children's Hospital
Enrollment
60
Locations
1
Primary Endpoint
Premature Infant Pain Profile
Status
Completed
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Sami Ulus Children's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dilek Dilli

Assoc Prof

Dr. Sami Ulus Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • VLBW infants \<32 weeks of gestational age

Exclusion Criteria

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

Outcomes

Primary Outcomes

Premature Infant Pain Profile

Time Frame: two hours

Premature Infant Pain Profile were determined after each eye examination

Secondary Outcomes

  • Crying time(two hours)

Study Sites (1)

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