Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy
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ClinicalTrials.gov Identifier: NCT02714699 |
Recruitment Status :
Completed
First Posted : March 21, 2016
Last Update Posted : January 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endoscopy | Drug: diclofenac potassium Drug: hyoscine butyl bromide Drug: placebo | Phase 2 Phase 3 |
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 |

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 |
- Mean pain score during hysteroscopy [ Time Frame: intraoperative ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients that must perform a diagnostic hysteroscopy.
- Acceptance to participate in the study.
- Signed informed consent.
- Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
- Absence of sedative use before admission
Exclusion Criteria:
- Hypersensitivity to drugs
- refusal of the patient
- Patients are pregnant.

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
Egypt | |
Ahmed Abbas | |
Assiut, Cairo, Egypt, 002 |
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 |
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