NCT02714699已完成2 期
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
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
- 129
- 试验地点
- 1
- 主要终点
- Mean pain score during hysteroscopy
研究概览
简要总结
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients that must perform a diagnostic hysteroscopy.
- •Acceptance to participate in the study.
- •Signed informed consent.
- •Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
- •Absence of sedative use before admission
排除标准
- •Hypersensitivity to drugs
- •refusal of the patient
- •Patients are pregnant.
研究组 & 干预措施
diclofenac potassium
Experimental
oral diclofenac potassium
干预措施: diclofenac potassium (Drug)
hyoscine butyl bromide
Active Comparator
oral hyoscine butyl bromide
干预措施: hyoscine butyl bromide (Drug)
placebo
Placebo Comparator
oral placebo
干预措施: placebo (Drug)
结局指标
主要结局
Mean pain score during hysteroscopy
时间窗: intraoperative
次要结局
未报告次要终点
研究者
研究点 (1)
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