NCT06398054

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: ASST Fatebenefratelli Sacco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg	Ibuprofen 400 mg tablet
DRUG	Hyoscine N-Butil Bromide	Hyoscine N-Butil Bromide 10 mg two tablets
DRUG	placebo	Two tablets

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-05-03
• Last updated: 2024-05-10