Comparison of the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy: a Randomized, Phase iv, Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 190
- 主要终点
- Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)
研究概览
简要总结
For outpatient hysteroscopy (OH), it is recommended to take a standard dose of NSAIDs or more hyoscine-n butyl bromide (HBB) an hour prior to the procedure to minimize pain during the first postoperative hour. As there is currently no clear consensus in the literature regarding the best approach to pain management associated with office hysteroscopy procedures. This Phase 4 study is being conducted to evaluate the effectiveness of oral ibuprofen alone and in combination with HBB to determine the most appropriate strategy for improving pain perception in outpatients.
详细描述
This is a randomized, phase IV, double-blind, placebo-controlled clinical trial.
The subjects will be randomly assigned into one of two treatment arms:
- Group A (Ibuprofen ): will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to HBB)
- Group B (Ibuprofen plus HHB): will assume one tablet of ibuprofen 400 mg plus two tablets of HHB 10 mg.
The purpose of this study is to evaluate the effectiveness of oral ibuprofen alone and in combination with HBB to determine the most appropriate strategy for improving pain perception in outpatients.
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)
盲法说明
Upon confirmation of eligibility, subjects will be randomly assigned (with a 1:1 allocation as per a computer generated randomization list with the same number of patients in each group) into one of two treatment arms
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients older than 18 years who signed informed consent;
- •patients who need an office hysteroscopy for their diagnosis or treatment. Those indications included postmenopausal endometrial thickening (over 4 mm), metrorrhagia, sonographic suspicion of endometrial polyps or myomas, Essure device insertion, and endometrial biopsy
排除标准
- •women with a possible pregnancy, ongoing vaginal bleeding, lower genital tract infection, gestational trophoblastic disease, asthma, hepatitis, renal failure, lactation, previous cervical surgery, or oversensitivity to one of the agents or their elements;
- •patients suffering from neuropathic pain or other conditions that can impact on the perception of pain;
- •individuals who use antidepressant, anxiolytics or other drugs/supplements that may have an impact on the perception of pain;
- •contraindications to the use of ibuprofen and/or Hyoscine N-Butil Bromide .
研究组 & 干预措施
Ibuprofen
will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to Hyoscine N-Butil Bromide)
干预措施: Ibuprofen 400 mg (Drug)
Ibuprofen
will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to Hyoscine N-Butil Bromide)
干预措施: placebo (Drug)
Ibuprofen plus HHB
will assume one tablet of ibuprofen 400 mg plus two tablets of Hyoscine N-Butil Bromid 10 mg.
干预措施: Ibuprofen 400 mg (Drug)
Ibuprofen plus HHB
will assume one tablet of ibuprofen 400 mg plus two tablets of Hyoscine N-Butil Bromid 10 mg.
干预措施: Hyoscine N-Butil Bromide (Drug)
结局指标
主要结局
Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)
时间窗: During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
The primary objective of this study is to determine the effectiveness of the use of ibuprofen 400 mg alone or a combination of 400 mg ibuprofen and 20 mg Hyoscine N-Butil Bromide, one hour before office hysteroscopy, has a different impact on reducing pain in patients.
次要结局
- Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)(During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure)
- Use of Visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)(5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure)
- Measure of the level of anxiety (through STAI-Y1 items, with a score from 1 to 4, where: 1 = not at all and 4 = very much)(During office hysteroscopy)
- Rate of adverse effects (percentage of events collected)(up to 24 hours)
研究者
Lorenzo Quirino
Principal Investigator, MD
ASST Fatebenefratelli Sacco