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Hyoscine Butyl Bromide in Reducing Pain During HSG (HBTB-DIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709603
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Relief With HSG Drug: hyoscine butyl bromide Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure
Drug: hyoscine butyl bromide
oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure
Other Name: BUSCOPAN

Placebo Comparator: Group B
oral 2 tablets (PLACEBO) 30 minutes before the procedure
Drug: placebo
oral placebo; 2 tablets 30 minutes before the procedure




Primary Outcome Measures :
  1. Mean pain score during. hysterosalpingography by visual analog scale [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Mean pain score after hysterosalpingography [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709603


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Ahmed Abbas
Assiut, Please Select, Egypt, 002
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: ahmed abbas, MD Woman health hospital Assiut

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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02709603    
Other Study ID Numbers: HS2
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Scopolamine
Bromides
Butylscopolammonium Bromide
Anticonvulsants
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics