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Efficacy of Ketoprofen Before Intrauterine Device Insertion

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02905058
Enrollment
100
Registered
2016-09-19
Start date
2016-10-31
Completion date
2017-07-31
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief

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.

Interventions

DRUGKetoprofen

oral non-steroidal antiinflammatory drug

DRUGplacebo

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Mean pain score during IUD insertion5 minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026