Efficacy of Ketoprofen Before Hysterosalpingography

November 11, 2017 updated by: Ahmed Mohamed Abbas, Assiut University

Effect of Oral Ketoprofen on Hysterosalpingography Pain: A Randomized Controlled Trial

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • 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 to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • any patient came for Hysterosalpingography

Exclusion Criteria:

  • any patient has contraindication to Hysterosalpingography

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: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ketoprofen
women will take one tablet 150 mg one hour before the procedure
Drug: Ketoprofen
Other Names:
  • bi profenid
PLACEBO_COMPARATOR: Placebo
women will take one tablet placebo one hour before the procedure
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean pain score during the procedure
Time Frame: 5 minutes
5 minutes

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)

July 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (ESTIMATE)

September 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 11, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KETOHSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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