Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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diclofenac potassium

oral diclofenac potassium

Group Type EXPERIMENTAL

diclofenac potassium

Intervention Type DRUG

patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure

hyoscine butyl bromide

oral hyoscine butyl bromide

Group Type ACTIVE_COMPARATOR

hyoscine butyl bromide

Intervention Type DRUG

patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure

placebo

oral placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

patients will take oral placebo; 2 tablets one hour before the procedure

Interventions

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diclofenac potassium

patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure

Intervention Type DRUG

hyoscine butyl bromide

patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure

Intervention Type DRUG

placebo

patients will take oral placebo; 2 tablets one hour before the procedure

Intervention Type DRUG

Other Intervention Names

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cataflam buscopan

Eligibility Criteria

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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