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

Overview

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.

Full Title of Study: “Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Premature Infant Pain Profile
    • Time Frame: two hours
    • Premature Infant Pain Profile were determined after each eye examination

Secondary Measures

  • Crying time
    • Time Frame: two hours
    • Crying time will be determined after each eye examination

Participating in This Clinical Trial

Inclusion Criteria

-VLBW infants <32 weeks of gestational age Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 3 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Sami Ulus Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dilek Dilli, Assoc Prof – Dr. Sami Ulus Children’s Hospital
  • Overall Official(s)
    • Eda Ç İlarslan, MD, Principal Investigator, MD

References

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.

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