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Completed

NCT Number: NCT02709603

Hyoscine Butyl Bromide in Reducing Pain During HSG

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.

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Key information

Conditions

Pain Relief With HSG

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abbas, Assiut, Cairo Governorate, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyoscine butyl bromide

Drug

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

Other names: BUSCOPAN

Placebo

Drug

oral placebo; 2 tablets 30 minutes before the procedure

Primary outcomes

  1. Mean pain score during. hysterosalpingography by visual analog scale

    Time frame: intraoperative

Secondary outcomes

  1. Mean pain score after hysterosalpingography

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG

Acronym: HBTB-DIC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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