A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ibuprofen 400 mg
  Ibuprofen 400 mg tablet
• Препарат Hyoscine N-Butil Bromide
  Hyoscine N-Butil Bromide 10 mg two tablets
• Препарат placebo
  Two tablets

Первичные конечные точки

• Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) [Срок оценки: During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure]

Вторичные конечные точки (4)

• Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: During office hysteroscopy]
• Rate of adverse effects (percentage of events collected) [Срок оценки: up to 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06398054 · HYSTPAIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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