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

NCT06398054 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-05-10

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Lorenzo Quirino · ASST Fatebenefratelli Sacco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398054 on ClinicalTrials.gov