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Efficacy of Ketoprofen Before Intrauterine Device Insertion

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02905058
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

IUD 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 IUD insertion tube, and removing the tube; and placement of the device in the uterus.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.

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 Intra Uterine Device Insertion Pain: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketoprofen

women will take one tablet 150 mg one hour before the procedure

Drug: Ketoprofen
oral non-steroidal antiinflammatory drug
Other Names:
  • bi profenid

    		•
    Placebo Comparator: Placebo

    women will take one placebo tablet one hour before the procedure

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. Mean pain score during IUD insertion [5 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women not taken analgesics or anxiolytics in the 24 hours prior insertion

    • Women not taken misoprostol prior to insertion

    • No contraindication to Non-steroidal drugs

    • Women who will accept to participate in the study

    Exclusion Criteria:
    • Any contraindication to device placement

    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:
    NCT02905058
    Other Study ID Numbers:
    • KETOIUD
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Nov 14, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Ketoprofen

    Study Results

    No Results Posted as of Nov 14, 2017