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

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ClinicalTrials.gov Identifier: NCT01811979
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 15, 2013
Last Update Posted Date May 9, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Premature Infant Pain Profile [ Time Frame: two hours ]
Premature Infant Pain Profile were determined after each eye examination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01811979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Crying time [ Time Frame: two hours ]
Crying time will be determined after each eye examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity
Official Title  ICMJE Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Investigate the Efficacy of Sucrose During Eye Examination
Intervention  ICMJE
  • Dietary Supplement: Oral sucrose solution
    Oral sucrose solution plus topical anesthetics
  • Dietary Supplement: Steril water
    steril water plus topical anesthetics
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Steril water
  • Placebo Comparator: steril water
    steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given
    Intervention: Dietary Supplement: Oral sucrose solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-VLBW infants <32 weeks of gestational age

Exclusion Criteria:

  • infants >32 weeks of gestational age
  • neuromuscular abnormality
  • major abnormality
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811979
Other Study ID Numbers  ICMJE 69/04.01.2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dilek Dilli, Dr. Sami Ulus Children's Hospital
Study Sponsor  ICMJE Dr. Sami Ulus Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eda Ç İlarslan, MD MD
PRS Account Dr. Sami Ulus Children's Hospital
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP