Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
研究概览
简要总结
The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.
详细描述
Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn.
Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently between 2 and 4 months of age
- •Birth between 37 and 42 weeks' completed gestation;
- •Birth weight greater than 2.5 kg
- •No evidence of acute or chronic disease processes.
排除标准
- •They are experiencing concurrent illness
- •They received an analgesic/sedative 6 hours prior to the office visit
- •The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization
- •The infant has been introduced to solid food
- •The infant may not receive a pacifier
- •The infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered
- •Language barriers preclude the process of obtaining parental consent.
结局指标
主要结局
The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
次要结局
- Duration of analgesia during immunizations
- Age related changes in behavioral pain response during immunizations