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

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

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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Pain profile score as assessed by NPASS

Secondary Outcome

 Number of adverse events

Condition

Retinopathy of Prematurity

Intervention

Sucrose

Study Arms / Comparison Groups

 Oral Sucrose

Description:  Oral sucrose administered 2 mins prior to eye exam

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

40

Start Date

August 2008

Completion Date

March 2009

Primary Completion Date

March 2009

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Eugene Dempsey, MD, FRCPI, , 

Location Countries

Ireland

Location Countries

Ireland

NCT ID

NCT00921544

Organization ID

Coombesucrose

Study Sponsor

Coombe Women and Infants University Hospital

Study Sponsor

Eugene Dempsey, MD, FRCPI, Study Director, Coombe Women and Infants University Hospital

Verification Date

June 2009