Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).
研究概览
简要总结
This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.
详细描述
Perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.
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 (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017
排除标准
- •Pregnant women with psychiatric disorder
- •Contraindicated to paracetamol
- •Pregnant women undergoing amniocentesis due to fetal anomaly
- •Take oral paracetamol or other analgesics within 24-48 hrs before operation
- •Deny to participate the research
研究组 & 干预措施
Comparator 2: Placebo oral
Drug: placebo Comparison pain score between paracetamol and placebo
干预措施: Placebo Oral Tablet (Drug)
Comparator1: Paracetamol 650 mg (325 mg/tablet) oral
Drug: Paracetamol Comparison pain score between paracetamol and placebo
干预措施: Paracetamol (Drug)
结局指标
主要结局
Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).
时间窗: 1 yrs
次要结局
未报告次要终点