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

Primary Purpose

Retinopathy of Prematurity

Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
Sucrose
Sterile water
Sponsored by
Coombe Women and Infants University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring ROP, sucrose, pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coombe Women and Infants University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Sucrose

Sterile water

Arm Description

Oral sucrose administered 2 mins prior to eye exam

0.2 mls of sterile water

Outcomes

Primary Outcome Measures

Pain profile score as assessed by NPASS

Secondary Outcome Measures

Number of adverse events

Full Information

First Posted
June 10, 2009
Last Updated
June 15, 2009
Sponsor
Coombe Women and Infants University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00921544
Brief Title
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
Official Title
Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Coombe Women and Infants University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
ROP, sucrose, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Sucrose
Arm Type
Active Comparator
Arm Description
Oral sucrose administered 2 mins prior to eye exam
Arm Title
Sterile water
Arm Type
Placebo Comparator
Arm Description
0.2 mls of sterile water
Intervention Type
Other
Intervention Name(s)
Sucrose
Other Intervention Name(s)
Sweeties
Intervention Description
0.2 ml sucrose 24% given by mouth using a syringe and pacifier
Intervention Type
Other
Intervention Name(s)
Sterile water
Intervention Description
Sterile water administered 2 mins prior to eye exam
Primary Outcome Measure Information:
Title
Pain profile score as assessed by NPASS
Time Frame
Scores assessed 3 months following completion of study
Secondary Outcome Measure Information:
Title
Number of adverse events
Time Frame
Assessed 3 months following completion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Dempsey, MD, FRCPI
Organizational Affiliation
Coombe Women and Infants University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Coombe Women and Infants University Maternity Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland

12. IPD Sharing Statement

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

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