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NCT02711358 Clinical Trial

Indomethacin Use in Pain Relief During Intrauterine Device Insertion

Family Planning Clinical Trial

— INDO-IUD  

Official title:
Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02711358
Other study ID # INDO
Secondary ID
Status Completed
Phase Phase 4
First received March 14, 2016
Last updated November 28, 2016
Start date March 2016
Est. completion date October 2016

Study information
Verified date November 2016
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 49 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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
• placebo
The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

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 intraoperative Yes
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