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NOT YET RECRUITING
NCT06398054
PHASE4

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

Sponsor: ASST Fatebenefratelli Sacco

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2024-10-01

Completion Date

2026-10-01

Last Updated

2024-05-10

Healthy Volunteers

No

Conditions

Interventions

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