NCT00921544

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Coombe Women and Infants University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-06-16
• Last updated: 2009-06-16

Locations

1 site across 1 country: Ireland