Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Coombe Women and Infants University Hospital Identifier:
First received: June 10, 2009
Last updated: June 15, 2009
Last verified: June 2009

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 Intervention Phase
Retinopathy of Prematurity
Other: Sucrose
Other: Sterile water
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Coombe Women and Infants University Hospital:

Primary Outcome Measures:
  • Pain profile score as assessed by NPASS [ Time Frame: Scores assessed 3 months following completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: Assessed 3 months following completion ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00921544

Coombe Women and Infants University Maternity Hospital
Dublin, Ireland, 8
Sponsors and Collaborators
Coombe Women and Infants University Hospital
Study Director: Eugene Dempsey, MD, FRCPI Coombe Women and Infants University Hospital
  More Information

No publications provided

Responsible Party: Eugene Dempsey, Coombe Women and Infants University Hospital Identifier: NCT00921544     History of Changes
Other Study ID Numbers: Coombesucrose
Study First Received: June 10, 2009
Last Updated: June 15, 2009
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Coombe Women and Infants University Hospital:

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases processed this record on March 01, 2015