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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921544
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
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.
Information provided by:
Coombe Women and Infants University Hospital
  Purpose
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
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

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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00921544


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

Responsible Party: Eugene Dempsey, Coombe Women and Infants University Hospital
ClinicalTrials.gov Identifier: NCT00921544     History of Changes
Other Study ID Numbers: Coombesucrose
First Submitted: June 10, 2009
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Coombe Women and Infants University Hospital:
ROP
sucrose
pain

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases