Hyoscine Butyl Bromide in Reducing Pain During HSG

NCT ID: NCT02709603

Last Updated: 2016-09-07

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Detailed Description

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Conditions

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Pain Relief With HSG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Group Type EXPERIMENTAL

hyoscine butyl bromide

Intervention Type DRUG

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Group B

oral 2 tablets (PLACEBO) 30 minutes before the procedure

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral placebo; 2 tablets 30 minutes before the procedure

Interventions

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hyoscine butyl bromide

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Intervention Type DRUG

placebo

oral placebo; 2 tablets 30 minutes before the procedure

Intervention Type DRUG

Other Intervention Names

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BUSCOPAN

Eligibility Criteria

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Inclusion Criteria

The infertile women who indicated for HSG.

Exclusion Criteria

* contraindications to Hyoscine or NSAID - known sensitivity to these drugs
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 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

Ahmed Abbas

Asyut, Please Select, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HS2

Identifier Type: -

Identifier Source: org_study_id

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