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Brief Title: The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

INTRODUCTION

  • Org Study ID: MedeniyetUro
  • Secondary ID: N/A
  • NTC ID: NCT03831321
  • Sponsor: Taha Uçar

BRIEF SUMMARY


The study was designed as a prospective, randomized double-blind placebo controlled trial.
According to power analysis in regards of previous studies in the literature with diclofenac
sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05.
diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2
individually. Patient randomization was performed using random.org in 144 patients. On the
day of cystoscopy, the patient randomized according to inclusion criteria will be given a
medication package corresponding to the number given in randomization. It will not be known
by the staff and cystoscopy will be performed by the physician who does not know which
package is an effective drug.

Parameters:

1. Visual Pain Score during cystoscopy

2. Cystoscopy comfort - a questionnaire to be filled by the doctor

1. Excellent

2. Very good

3. Good

4. Bad

5. Too bad

3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.

Post-Op:

1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency

2. 24th Hour dysuria, Frequency,

A total of 144 patients, we plan to arrive at the end of 1 month.


  • Overall Status
    Recruiting
  • Start Date
    December 11, 2018
  • Phase
    Phase 4
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Assesment for operational pain

Primary Outcome 1 - Timeframe: 1 minute

CONDITION

  • Bladder Cancer
  • Benign Prostate Hyperplasia
  • Hematuria
  • Pain
  • Lower Urinary Tract Symptoms

ELIGIBILITY


Inclusion Criteria:

- Accepted to participate

- 18-70 years old

- Men

Exclusion Criteria:

1. Previous peptic ulcer

2. Gastro intestinal bleeding in advance

3. Renal failure

4. Liver failure

5. Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug
allergies

7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9-
Patients who do not agree to participate in the study

Gender: Male

Minimum Age: 70 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Asıf Yıldırım

Role: Study Director

Affiliation: Medeniyet University

Overall Contact

Name: Asıf Yıldırım

Phone: 05353044736

Email: ucartaha@gmail.com

LOCATION

Facility Status Contact
Facility: Medeniyet University
Istanbul, Outside U.S./Canada
Turkey
Status: Recruiting Contact:
Taha Uçar
5353044736