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

Retinopathy of Prematurity Clinical Trial

Official title:

Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921544
• Other study ID #: Coombesucrose
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2009
• Last updated: June 15, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Coombe Women and Infants University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Sucrose
0.2 ml sucrose 24% given by mouth using a syringe and pacifier
• Sterile water
Sterile water administered 2 mins prior to eye exam

Locations

Country	Name	City	State
Ireland	Coombe Women and Infants University Maternity Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Coombe Women and Infants University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain profile score as assessed by NPASS		Scores assessed 3 months following completion of study	No
Secondary	Number of adverse events		Assessed 3 months following completion	Yes