Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

Phase 2

Completed

• Conditions: Endoscopy
• Interventions: Drug: hyoscine butyl bromide; Drug: placebo; Drug: diclofenac potassium

• Registration Number: NCT02714699
• Lead Sponsor: Assiut University

Brief Summary

The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-21
• Study Start: 2016-10
• Primary Completion: 2017-03
• Study Completion: 2017-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

Inclusion Criteria

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
5. Absence of sedative use before admission

Exclusion Criteria

1. Hypersensitivity to drugs
2. refusal of the patient
3. Patients are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyoscine butyl bromide	hyoscine butyl bromide	oral hyoscine butyl bromide
placebo	placebo	oral placebo
diclofenac potassium	diclofenac potassium	oral diclofenac potassium

Primary Outcome Measures

Name	Time	Method
Mean pain score during hysteroscopy	intraoperative

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt