Trial | NCT00921544  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Sucrose ...

  • Study Participants

    40
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 Started
Aug 31
2008
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Last Update
Jun 16
2009
Estimate

Other Sterile water

Sterile water administered 2 mins prior to eye exam

Other Sucrose

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

  • Other names: Sweeties

Oral Sucrose Active Comparator

Oral sucrose administered 2 mins prior to eye exam

Sterile water Placebo Comparator

0.2 mls of sterile water

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
No Results Posted