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NCT02714699 Clinical Trial

Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

Endoscopy Clinical Trial

Official title:
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02714699
Other study ID # HB-OH
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 16, 2016
Last updated January 4, 2018
Start date October 2016
Est. completion date May 2017

Study information
Verified date January 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• diclofenac potassium
patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
• hyoscine butyl bromide
patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
• placebo
patients will take oral placebo; 2 tablets one hour before the procedure

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean pain score during hysteroscopy intraoperative
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