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

NCT ID: NCT00921544

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-03-31

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.

Conditions

Retinopathy of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Sucrose

Oral sucrose administered 2 mins prior to eye exam

Group Type: ACTIVE_COMPARATOR

Sucrose

Intervention Type: OTHER

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

Sterile water

0.2 mls of sterile water

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: OTHER

Sterile water administered 2 mins prior to eye exam

Interventions

Sucrose

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

Intervention Type: OTHER

Sterile water

Sterile water administered 2 mins prior to eye exam

Intervention Type: OTHER

Other Intervention Names

Sweeties

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coombe Women and Infants University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Coombe Women and Infants University Hospital

Principal Investigators

Eugene Dempsey, MD, FRCPI

Role: STUDY_DIRECTOR

Coombe Women and Infants University Hospital

Locations

Coombe Women and Infants University Maternity Hospital

Dublin, Dublin, Ireland

Countries

Ireland

Other Identifiers

Coombesucrose

Identifier Type: -

Identifier Source: org_study_id