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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

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.

Condition or disease Intervention/treatment Phase
Investigate the Efficacy of Sucrose During Eye Examination Dietary Supplement: Oral sucrose solution Dietary Supplement: Steril water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
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
Dietary Supplement: Steril water
steril water plus topical anesthetics

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




Primary Outcome Measures :
  1. Premature Infant Pain Profile [ Time Frame: two hours ]
    Premature Infant Pain Profile were determined after each eye examination


Secondary Outcome Measures :
  1. Crying time [ Time Frame: two hours ]
    Crying time will be determined after each eye examination



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-VLBW infants <32 weeks of gestational age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811979


Locations
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Turkey
Dr Sami Ulus Children Hospital
Ankara, Turkey
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Principal Investigator: Eda Ç İlarslan, MD MD

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01811979     History of Changes
Other Study ID Numbers: 69/04.01.2012
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by Dilek Dilli, Dr. Sami Ulus Children's Hospital:
eye examination, oral sucrose, premature infant pain scale

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Retinal Diseases
Infant, Premature, Diseases
Eye Diseases
Infant, Newborn, Diseases
Pharmaceutical Solutions
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents