drugset / Trial / NCT06398054

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

NCT06398054

Phase 4 Not yet recruiting 190 enrolled ASST Fatebenefratelli Sacco
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-10-01
Primary completion
2026-10-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BUTYLSCOPOLAMINE Small molecule 10 mg
Subject Ibuprofen Small molecule 400 mg Oral

Indications

No indication recorded.