Clinical trial · Interventional
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostate Hyperplasia | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hematuria | — | UNRESOLVED | — |
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cystoscopy | Device | — | UNRESOLVED |
| Diclofenac Sodium | Drug | — | UNRESOLVED |
| Lubricant Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diclofenac group
- description
- The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
- interventionNames
- Drug: Diclofenac Sodium
- Device: Cystoscopy
- Drug: Lubricant Gel
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
- interventionNames
- Device: Cystoscopy
- Drug: Lubricant Gel
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available