Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.
OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.
STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.
POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.
OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.
Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- Male
- 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
- •Apgar scores a minimum of 7 at 1 and 5 minutes respectively
- •Heart rate between 100 and 160 per minutes
- •Blood O2 saturation of at least 95%
- •No recognized congenital abnormalities
排除标准
- •They were transferred to the neonatal intensive care unit (NICU)
- •They required respiratory support
结局指标
主要结局
Pain score
时间窗: Pain will be assessed 1 minute before the procedure and during the procedure
Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.
次要结局
- Oxygen saturation(2 minutes before the procedure, during the procedure and one minute after the procedure)
- Respiratory rate(2 minutes before the procedure, during the procedure and one minute after the procedure)
- Heart rate(2 minutes before the procedure, during the procedure and one minute after the procedure)
研究者
Amal Naous
Pediatrician
Makassed General Hospital