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

Phase 4Not Yet RecruitingNCT06398054

ASST Fatebenefratelli Sacco190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 .

Outcomes

Primary Outcomes

Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

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.

Time frame: During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure

Secondary Outcomes

Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

To assess a different response to analgesic treatment between nullipare and multipare

Time frame: 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)

To evaluate response in post menopausal condition

Time frame: 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)

Measure of the level of pre-procedural anxiety through the STAI-Y (scoring range: 20-80; cut-off: 39-40)

Time frame: During office hysteroscopy

Rate of adverse effects (percentage of events collected)

Determine the safety profile of the study medications

Time frame: up to 24 hours