Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Pain measure
研究概览
简要总结
Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.
Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.
Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.
Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.
Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.
详细描述
Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
RCT, blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •indication of intrauterine evaluation
- •Abnormal uterine bleeding
- •post-menopause uterine bleeding
- •infertility
- •recurrent miscarriage
排除标准
- •stenosis of the external cervical orifice,
- •pelvic inflammatory disease,
- •suspected gestation or pregnancy,
- •active bleeding at the time of examination
- •contraindication to the use of the study medication, diclofenac sodium and scopolamine,
研究组 & 干预措施
Placebo Oral + Placebo Oral
Placebo Oral + Placebo Oral
干预措施: Placebo Oral + Placebo Oral (Drug)
Diclofenac oral + Placebo Oral
Diclofenac oral + Placebo Oral
干预措施: Diclofenac oral + Placebo Oral (Drug)
Diclofenac oral + scopolamina oral
Diclofenac oral + scopolamina oral
干预措施: Diclofenac oral + scopolamina oral (Drug)
结局指标
主要结局
Pain measure
时间窗: until 1 hour after exam
Pain Visual analogue score
次要结局
- Likert scale(until 1 hour after exam)