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NCT02714231 Clinical Trial

Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion

Family Planning Clinical Trial

Official title:
A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02714231
Other study ID # DS-HB
Secondary ID
Status Completed
Phase Phase 4
First received March 14, 2016
Last updated July 15, 2017
Start date March 2016
Est. completion date March 2017

Study information
Verified date July 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 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

Related Conditions & MeSH terms

Intervention

Drug:
• diclofenac sodium (cataflam)
The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure
• hyoscine butyl bromide (buscopan)
The patients in the study group will take one tablet of buscopan 10 mg 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 insertion intraoperative
Secondary Patient satisfaction score 5 minutes
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