NCT00949104已完成2 期
A Study to Assess the Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Painful response as assessed by PIPP Scale
研究概览
简要总结
RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT insertion reduces pain associated with the procedure.
AIMS AND OBJECTIVES:
To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube insertion .
详细描述
MATERIAL & METHODS
PARTICPANTS:
INCLUSION CRITERIA: The enrolled participants must fulfill the following inclusion criteria:
- All pre-terms ( < 37 weeks of gestational age.)
- Within the first 7 days postnatal days (</=168 hours).
- Clinically stable from respiratory, hemodynamic and metabolic point of view.
- Who have not received any painful stimulus at least 30 minutes prior to the intervention.
- Requiring routine orogastric tube insertion within the first 7 days of life.
- Only the first attempt at putting OGT in controlled NICU environment will be considered
EXCLUSION CRITERIA: The neonates with the following characteristics will be excluded from the study:
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
- 1 Hour 至 167 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pre-terms ( < 37 weeks of gestational age.)
- •Within the first 7 days postnatal days (</=168 hours).
- •Clinically stable from respiratory, hemodynamic and metabolic point of view.
- •Who have not received any painful stimulus at least 30 minutes prior to the intervention.
- •Requiring routine orogastric tube insertion within the first 7 days of life.
- •Only the first attempt at putting OGT in controlled NICU environment will be considered
排除标准
- •The neonates with the following characteristics will be excluded from the study:
- •Neonates requiring ventilatory support.
- •Neonates requiring oxygen supplementation.
- •Having any facial congenital anomalies.
- •Having any neurological impairment.
- •Receiving opiates or born to mothers receiving opiates.
- •New born babies to whom muscle relaxants, sedatives and analgesics have been administered.
- •With grade 3 and 4 IVH.
- •With major congenital anomalies
- •Any history of birth trauma especially involving face or scalp (including cephalhematoma/ subgaleal bleed).
- •Face presentation.
研究组 & 干预措施
Sucrose
Active Comparator
1 ml of 24% sucrose was administered 2 minutes before the procedure
干预措施: Sucrose (Drug)
Placebo
Placebo Comparator
Double distilled water
干预措施: Double distilled water (Drug)
结局指标
主要结局
Painful response as assessed by PIPP Scale
时间窗: Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes
次要结局
- Maximum heart rate and minimum oxygen saturation(pre procedure,intra procedure,post 30 seconds,post 1 minute,post 2 minute)
研究者
研究点 (1)
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