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Completed

NCT Number: NCT02714699

Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

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

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Key information

Conditions

Endoscopy

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Diclofenac Potassium

Drug

patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure

Other names: cataflam

hyoscine butyl bromide

Drug

patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure

Other names: buscopan

Placebo

Drug

patients will take oral placebo; 2 tablets one hour before the procedure

Primary outcomes

  1. Mean pain score during hysteroscopy

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Jan 5, 2018

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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