Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Behavioral pain response
研究概览
简要总结
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
详细描述
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.
Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine 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 (Participant, Investigator)
盲法说明
Double Blind (subject, Investigator)
入排标准
- 年龄范围
- 3 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently between 4 and 11 months of age;
- •Between 37 and 42 weeks' completed gestation at birth;
- •Birth weight greater than 2.5 kg; and
- •No evidence of acute or chronic disease
排除标准
- •Fed 30 minutes prior to immunization;
- •Received analgesic/sedative the day of the immunizations;
- •Parent wishes to feed the infant during the immunizations;
- •Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
- •Language barriers preclude the process of obtaining parental consent.
研究组 & 干预措施
Sucrose
Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.
干预措施: Administration of oral Sucrose (Other)
Placebo
Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.
干预措施: Administration of oral Placebo (Other)
结局指标
主要结局
Behavioral pain response
时间窗: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine
Infants will be evaluated based on the University of Wisconsin Children's Hospital Pain Scale to score an infant's pain. Possible scores range from 0 (no pain) to 5 (worst possible pain).
次要结局
未报告次要终点