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OpenTrials
Completed

NCT Number: NCT02905058

Efficacy of Ketoprofen Before Intrauterine Device Insertion

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.

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Key information

Conditions

Pain Relief

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoprofen

Drug

oral non-steroidal antiinflammatory drug

Other names: bi profenid

Placebo

Drug

Primary outcomes

  1. Mean pain score during IUD insertion

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Oral Ketoprofen on Intra Uterine Device Insertion Pain: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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