Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

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

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

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Detailed Description

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Conditions

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Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

oral hyoscine butyl bromide tablets plus lidocaine cream

Group Type ACTIVE_COMPARATOR

oral hyoscine butyl bromide tablets plus lidocaine cream

Intervention Type DRUG

patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure

Group B

oral placebo tablets plus placebo cream

Group Type PLACEBO_COMPARATOR

oral placebo tablets plus placebo cream

Intervention Type DRUG

patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure

Interventions

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oral hyoscine butyl bromide tablets plus lidocaine cream

patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure

Intervention Type DRUG

oral placebo tablets plus placebo cream

patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• The infertile women who indicated for HSG

Exclusion Criteria

* contraindications to Hyoscine or lidocaine
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No