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

NCT00921544 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-06-16

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

OTHER

Sucrose

0.2 ml sucrose 24% given by mouth using a syringe and pacifier

OTHER

Sterile water

Sterile water administered 2 mins prior to eye exam

Sponsors & Collaborators

  • Coombe Women and Infants University Hospital

    lead OTHER

Principal Investigators

  • Eugene Dempsey, MD, FRCPI · Coombe Women and Infants University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921544 on ClinicalTrials.gov