Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Diagnostic test: Diclofenac + HBB with hysteroscopy; Diagnostic test: Diclofenav + placebo

Detailed Description

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Algazeerah and Kasralainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 1. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs

Exclusion Criteria:

• 1. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diclofenac + HBB; Women who will receive Diclofenac + HBB	Diagnostic test: Diclofenac + HBB with hysteroscopy; Giving Diclofenac + HBB with hysteroscopy; Diagnostic test: Diclofenav + placebo; Giving Diclofenac + placebo with hysteroscopy
Other: Diclofenav + placebo; Women who will receive Diclofenav + placebo	Diagnostic test: Diclofenac + HBB with hysteroscopy; Giving Diclofenac + HBB with hysteroscopy; Diagnostic test: Diclofenav + placebo; Giving Diclofenac + placebo with hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of women who will not feel pain	the effect of medications on pain sensation	within half an hour

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2020
• Primary Completion (Actual): August 25, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: Diclofenac potassium

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No