Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Background: It was long believed that newborns could not experience pain. As it is now documented that newborns have all the necessary systems to perceive pain, pain management can no longer be ignored.
Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and still there is debate regarding the efficacy of oral glucose, in different strengths, on alleviation of pain among neonates.
Aim: The objective of this study is to assess the efficacy and safety oral administration of glucose, in different concentrations, on pain relief in full term neonates undergoing heel prick test.
Methods: The investigators will conduct a prospective, randomized, double blind placebo controlled trial to investigate the effect of glucose solution on alleviating the pain of heel prick test in 244 healthy full term newborns who will be randomly allocated to one of three groups: First group will receive 5% glucose, second group will receive 30% glucose and third group will receive sterile water as a placebo, 2 minutes prior to the procedure.
Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in heart rate, respiratory rate and oxygen saturation.
详细描述
The investigators will conduct a prospective, randomized, double blind, placebo controlled study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel prick test. They will be randomized to receive either 5% glucose, 30% glucose or sterile water as a placebo, 2 minutes prior to the procedure. The investigators will study the efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile water) in pain alleviation.
All parents will receive an explanation of the study before participation, and informed written consent will be signed by the parents for voluntary participation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 24 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age: 37 weeks-42 weeks
- •Birth weight: 2500 grams- 4000 grams
- •Mode of delivery: normal vaginal delivery
- •Age: birth to 72 hours of life
- •Apgar scores of at least 7 at 1 and 5 minutes
- •Heart rate between 100 and 160 per minutes
- •Blood O2 saturation ≥ 95%
- •No known congenital anomalies
排除标准
- •They have history of birth trauma
- •They are admitted to neonatal intensive care unit (NICU)
- •They need respiratory support
- •Their mothers are receiving sedatives or opioids during vaginal delivery
结局指标
主要结局
Pain score
时间窗: 2 minutes during the procedure
Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS
次要结局
- Occurance of adverse events(5 minutes after the procedure)
研究者
Amal Naous
Pediatrician
Makassed General Hospital