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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02714231

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Family Planning	Drug: diclofenac sodium (cataflam) Drug: hyoscine butyl bromide (buscopan)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diclofenac oral diclofuhenac sodium	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
Active Comparator: hyoscine oral hyoscine butyl bromide	Drug: 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

Arm

Intervention/Treatment

Experimental: diclofenac

oral diclofuhenac sodium

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

Active Comparator: hyoscine

oral hyoscine butyl bromide

Drug: 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

Outcome Measures

Primary Outcome Measures

Mean pain score during insertion [intraoperative]

Secondary Outcome Measures

Patient satisfaction score [5 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: ahmed abbas, MD, Woman health hospital Assiut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02714231

Other Study ID Numbers:

DS-HB

First Posted:

Mar 21, 2016

Last Update Posted:

Jul 19, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Diclofenac

Scopolamine

Bromides

Butylscopolammonium Bromide

Study Results

No Results Posted as of Jul 19, 2017