NCT03831321

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Taha Uçar · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium	50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy.
DEVICE	Cystoscopy	Diagnostic cystoscopy
DRUG	Lubricant Gel	To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)

Timeline

• Start date: 2018-12-11
• Primary completion: 2019-04-22
• Completion: 2019-05-22
• First posted: 2019-02-05
• Last updated: 2019-02-05

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study