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

NCT ID: NCT02714231

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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Conditions

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Family Planning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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diclofenac

oral diclofuhenac sodium

Group Type EXPERIMENTAL

diclofenac sodium (cataflam)

Intervention Type DRUG

The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure

hyoscine

oral hyoscine butyl bromide

Group Type ACTIVE_COMPARATOR

hyoscine butyl bromide (buscopan)

Intervention Type DRUG

The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed abbas, MD

Role: PRINCIPAL_INVESTIGATOR

Woman health hospital Assiut

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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DS-HB

Identifier Type: -

Identifier Source: org_study_id

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