Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
研究概览
简要总结
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
详细描述
All healthy, fullterm infants undergoes a medical examination after birth where 21 different components are assessed. One of the components is the hip examination which appears to be painful. Since painful experiences early in life can cause longterm negative effects it is important to treat pain during painful procedures.
One hundred healthy, fullterm infants were randomized to either glucose or sterile water orally before the routine medical examination before discharge from the maternity ward.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy, fullterm infants that were undergoing a routine medical examination
排除标准
- •Prematurity
- •Parents inability to speak Swedish well enough to give consent
- •Congenital malformations or other illnesses
- •Any pain-relieving medicine administered in the previous 24 hours
研究组 & 干预措施
30% glucose
This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.
干预措施: 30% glucose (Drug)
Sterile water
This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.
干预措施: Sterile water (Drug)
结局指标
主要结局
Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
时间窗: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.
Pain assessment instrument
Crying time during hip examination
时间窗: The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch
The amount of time (in minutes) the infant is crying during the hip examination.
Total crying time will be measured
时间窗: The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.
Total amount of time (in minutes) the infant is crying during the examination.
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician
时间窗: The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Pain assessment instrument
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent
时间窗: The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Pain assessment instrument
次要结局
未报告次要终点