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Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

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: NCT02714699
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Study Description
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Brief Summary:
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy

Condition or disease Intervention/treatment Phase
Endoscopy Drug: diclofenac potassium Drug: hyoscine butyl bromide Drug: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: diclofenac potassium
oral diclofenac potassium
 Drug: diclofenac potassium
patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
Other Name: cataflam
Active Comparator: hyoscine butyl bromide
oral hyoscine butyl bromide
 Drug: hyoscine butyl bromide
patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
Other Name: buscopan
Placebo Comparator: placebo
oral placebo
 Drug: placebo
patients will take oral placebo; 2 tablets one hour before the procedure


Outcome Measures
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Primary Outcome Measures :
  1. Mean pain score during hysteroscopy [ Time Frame: intraoperative ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients that must perform a diagnostic hysteroscopy.
  2. Acceptance to participate in the study.
  3. Signed informed consent.
  4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
  5. Absence of sedative use before admission

Exclusion Criteria:

  1. Hypersensitivity to drugs
  2. refusal of the patient
  3. Patients are pregnant.
Contacts and Locations
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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): NCT02714699


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02714699    
Other Study ID Numbers: HB-OH
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diclofenac
Scopolamine
Bromides
Butylscopolammonium Bromide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Muscarinic Antagonists
Parasympatholytics