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

NCT00921544 | Completed Phase 4

• 1 other identifier: Coombesucrose
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

ROP; sucrose; pain

Outcome Measures

Primary Outcomes (1)

• Pain profile score as assessed by NPASS

  Scores assessed 3 months following completion of study

Secondary Outcomes (1)

• Number of adverse events

  Assessed 3 months following completion

Study Arms (2)

Oral Sucrose

ACTIVE COMPARATOR

Oral sucrose administered 2 mins prior to eye exam

Other: Sucrose

Sterile water

PLACEBO COMPARATOR

0.2 mls of sterile water

Other: Sterile water

Interventions

Sucrose OTHER

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

Also known as: Sweeties

Oral Sucrose

Sterile water OTHER

Sterile water administered 2 mins prior to eye exam

Sterile water

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 1500 grams
• \< 32 weeks

You may not qualify if:

• Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
• Infants where consent to participate was not obtained

Sponsors & Collaborators

• Coombe Women and Infants University Hospital: lead

Study Sites (1)

Coombe Women and Infants University Maternity Hospital

Dublin, Dublin, 8, Ireland

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Eugene Dempsey, MD, FRCPI

  Coombe Women and Infants University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 16, 2009
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

IE (1)