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NCT01811979 Clinical Trial

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

Investigate the Efficacy of Sucrose During Eye Examination Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01811979
Other study ID # 69/04.01.2012
Secondary ID
Status Completed
Phase N/A
First received March 13, 2013
Last updated May 7, 2013
Start date April 2012
Est. completion date May 2013

Study information
Verified date May 2013
Source Dr. Sami Ulus Children's Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

-VLBW infants <32 weeks of gestational age

Exclusion Criteria:

- infants >32 weeks of gestational age

- neuromuscular abnormality

- major abnormality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral sucrose solution
Oral sucrose solution plus topical anesthetics
• Steril water
steril water plus topical anesthetics

Locations
Country Name City State
Turkey Dr Sami Ulus Children Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Premature Infant Pain Profile Premature Infant Pain Profile were determined after each eye examination two hours No
Secondary Crying time Crying time will be determined after each eye examination two hours No

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