Indomethacin Use in Pain Relief During Intrauterine Device Insertion

Overview

The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.

Full Title of Study: “Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2016

Interventions

  • Drug: indomethacin suppositories
    • The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure
  • Drug: placebo
    • The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

Arms, Groups and Cohorts

  • Experimental: indomethacin
    • indomethacin suppositories
  • Placebo Comparator: placebo
    • placebo suppositories

Clinical Trial Outcome Measures

Primary Measures

  • Mean pain score during IUD insertion
    • Time Frame: intraoperative

Participating in This Clinical Trial

Inclusion Criteria

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion – Women not taken misoprostol prior to intrauterine device insertion – Women who will accept to participate in the study Exclusion Criteria:

  • Any contraindication to intrauterine device placement

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Mohamed Abbas, Dr – Assiut University

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