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Completed

NCT Number: NCT00921544

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coombe Women and Infants University Maternity Hospital

Dublin, 8, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucrose

Other

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

Other names: Sweeties

Sterile Water

Other

Sterile water administered 2 mins prior to eye exam

Primary outcomes

  1. Pain profile score as assessed by NPASS

    Time frame: Scores assessed 3 months following completion of study

Secondary outcomes

  1. Number of adverse events

    Time frame: Assessed 3 months following completion

Sponsors and collaborators

Lead sponsor

Coombe Women and Infants University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2009
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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