NCT00725218已完成4 期
Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- VAS pain scorings
研究概览
简要总结
Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA status I-II
- •Performing abortion operation (medical- or drug-induced
- •Requiring painless abortion
排除标准
- •< 19yrs, and >= 45yrs
- •History of central active drugs administration
- •Drug abuse
- •Hypertension
- •Any other chronic diseases
- •Allergy to the study drugs
- •Habit of over-volume alcohol drinking
- •Records of history of centrally active drug use and psychiatry
- •Any organic disorders
研究组 & 干预措施
1
Placebo Comparator
Saline 5 ml injection 10 min prior to propofol administration.
干预措施: Saline (Drug)
2
Experimental
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
干预措施: Flurbiprofen Axetil (Drug)
结局指标
主要结局
VAS pain scorings
时间窗: At the end of the operation, 0,5,15,30,60min after operation
次要结局
- Anesthetic consumptions(At the end of the operation)
- Overall VAS satisfaction scorings with analgesia(At the end of the study)
- Side effects(During the whole period of the study)
- Volume of bleeding(At the end of the study)
研究者
研究点 (1)
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