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

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 .