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Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921544
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Information provided by:
Coombe Women and Infants University Hospital

Brief Summary:
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Other: Sucrose Other: Sterile water Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Active Comparator: Oral Sucrose
Oral sucrose administered 2 mins prior to eye exam
Other: Sucrose
0.2 ml sucrose 24% given by mouth using a syringe and pacifier
Other Name: Sweeties

Placebo Comparator: Sterile water
0.2 mls of sterile water
Other: Sterile water
Sterile water administered 2 mins prior to eye exam

Primary Outcome Measures :
  1. Pain profile score as assessed by NPASS [ Time Frame: Scores assessed 3 months following completion of study ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: Assessed 3 months following completion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • < 1500 grams
  • < 32 weeks

Exclusion Criteria:

  • Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
  • Infants where consent to participate was not obtained

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 identifier (NCT number): NCT00921544

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Coombe Women and Infants University Maternity Hospital
Dublin, Ireland, 8
Sponsors and Collaborators
Coombe Women and Infants University Hospital
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Study Director: Eugene Dempsey, MD, FRCPI Coombe Women and Infants University Hospital
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Responsible Party: Eugene Dempsey, Coombe Women and Infants University Hospital Identifier: NCT00921544    
Other Study ID Numbers: Coombesucrose
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009
Keywords provided by Coombe Women and Infants University Hospital:
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases