Efficacy of Ketoprofen Before Intrauterine Device Insertion

Assiut University

Status and phase: Completed; Phase 3

Conditions: Pain Relief

Treatments: Drug: Ketoprofen; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02905058

KETOIUD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Ketoprofen

Experimental group

Description:

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

Treatment:

Drug: Ketoprofen

Placebo

Placebo Comparator group

Description:

women will take one placebo tablet one hour before the procedure

Treatment:

Drug: placebo