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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398054
• Other study ID #: HYSTPAIN
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2024
• Source: ASST Fatebenefratelli Sacco
• Contact: Lorenzo Quirino
• Phone: 02. 63632349
• Email: lorenzo.quirino[@]asst-fbf-sacco.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ASST Fatebenefratelli Sacco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
Secondary	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	During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
Secondary	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	5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
Secondary	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)	During office hysteroscopy
Secondary	Rate of adverse effects (percentage of events collected)	Determine the safety profile of the study medications	up to 24 hours