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Efficacy of Ketoprofen Before Hysterosalpingography

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02905045
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Oral Ketoprofen on Hysterosalpingography Pain: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Mean pain score during the procedure [5 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • any patient came for Hysterosalpingography
    Exclusion Criteria:
    • any patient has contraindication to Hysterosalpingography

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Abbas Assiut Cairo Egypt 002

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed Abbas, Dr, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02905045
    Other Study ID Numbers:
    • KETOHSG
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Nov 14, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Ketoprofen

    Study Results

    No Results Posted as of Nov 14, 2017