Efficacy of Ketoprofen Before Intrauterine Device Insertion

Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905058
• Other study ID #: KETOIUD
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2016
• Last updated: November 11, 2017
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Relief

Intervention

Drug:
• Ketoprofen
oral non-steroidal antiinflammatory drug
• placebo

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score during IUD insertion		5 minutes