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

This study has been completed.
Sponsor:
Information provided by:
Coombe Women and Infants University Hospital
ClinicalTrials.gov Identifier:
NCT00921544
First received: June 10, 2009
Last updated: June 15, 2009
Last verified: June 2009

June 10, 2009
June 15, 2009
August 2008
March 2009   (final data collection date for primary outcome measure)
Pain profile score as assessed by NPASS [ Time Frame: Scores assessed 3 months following completion of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921544 on ClinicalTrials.gov Archive Site
Number of adverse events [ Time Frame: Assessed 3 months following completion ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Retinopathy of Prematurity
  • Other: Sucrose
    0.2 ml sucrose 24% given by mouth using a syringe and pacifier
    Other Name: Sweeties
  • Other: Sterile water
    Sterile water administered 2 mins prior to eye exam
  • Active Comparator: Oral Sucrose
    Oral sucrose administered 2 mins prior to eye exam
    Intervention: Other: Sucrose
  • Placebo Comparator: Sterile water
    0.2 mls of sterile water
    Intervention: Other: Sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT00921544
Coombesucrose
No
Eugene Dempsey, Coombe Women and Infants University Hospital
Coombe Women and Infants University Hospital
Not Provided
Study Director: Eugene Dempsey, MD, FRCPI Coombe Women and Infants University Hospital
Coombe Women and Infants University Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP