NCT00213213Unknown不适用
Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
研究概览
简要总结
This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.
We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.
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
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy newborn infants ≥36 weeks gestation
- •infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes
排除标准
- •Admission to the neonatal intensive care unit
- •plan to undergo circumcision during the study period
- •major congenital or neurological anomalies
- •clinical diagnosis of birth asphyxia or seizures
- •receiving analgesics or sedatives
结局指标
主要结局
- Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
次要结局
- (effectiveness):
- - Effectiveness of sucrose for repeated heel lances
- - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
- - Effectiveness of sucrose in decreasing pain response during Vitamin K injection
- - Determination of relationship between painful procedures and infant response during routine care procedures
- (safety):
- - Incidence of vomiting during administration of sucrose
- - Oxygen saturation during administration of sucrose
- - Serum Glucose concentrations in infants of diabetic mothers
研究者
研究点 (2)
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