Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

January 4, 2018 updated by: Ahmed Mohamed Abbas, Assiut University

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: diclofenac potassium
oral diclofenac potassium
Drug: diclofenac potassium
patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
Other Names:
  • cataflam
ACTIVE_COMPARATOR: hyoscine butyl bromide
oral hyoscine butyl bromide
Drug: hyoscine butyl bromide
patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
Other Names:
  • buscopan
PLACEBO_COMPARATOR: placebo
oral placebo
Drug: placebo
patients will take oral placebo; 2 tablets one hour before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean pain score during hysteroscopy
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB-OH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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