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

Phase 4

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Other: Sucrose; Other: Sterile water

• Registration Number: NCT00921544
• Lead Sponsor: Coombe Women and Infants University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-06
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-15
• Last Update Submitted: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Posted: 2009-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Sucrose	Sucrose	Oral sucrose administered 2 mins prior to eye exam
Sterile water	Sterile water	0.2 mls of sterile water

Primary Outcome Measures

Name	Time	Method
Pain profile score as assessed by NPASS	Scores assessed 3 months following completion of study

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Assessed 3 months following completion

Trial Locations

Locations (1)

Coombe Women and Infants University Maternity Hospital; 🇮🇪 Dublin, Ireland