跳至主要内容
临床试验/NCT00921544
NCT00921544已完成4 期

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

Coombe Women and Infants University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Pain profile score as assessed by NPASS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • < 1500 grams
  • < 32 weeks

排除标准

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

结局指标

主要结局

Pain profile score as assessed by NPASS

时间窗: Scores assessed 3 months following completion of study

次要结局

  • Number of adverse events(Assessed 3 months following completion)

研究者

发起方
Coombe Women and Infants University Hospital
申办方类型
Other

研究点 (2)

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