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Efficacy of Ketoprofen Before Intrauterine Device Insertion

Phase 3
Completed
Conditions
Pain Relief
Interventions
Drug: placebo
Registration Number
NCT02905058
Lead Sponsor
Assiut University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
KetoprofenKetoprofenwomen will take one tablet 150 mg one hour before the procedure
Placeboplacebowomen will take one placebo tablet one hour before the procedure
Primary Outcome Measures
NameTimeMethod
Mean pain score during IUD insertion5 minutes
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ahmed Abbas

🇪🇬

Assiut, Cairo, Egypt

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