The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
- Conditions
- Benign Prostate HyperplasiaHematuriaBladder CancerPainLower Urinary Tract Symptoms
- Interventions
- Registration Number
- NCT03831321
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 144
- Accepted to participate
- 18-70 years old
- Men
- Previous peptic ulcer
- Gastro intestinal bleeding in advance
- Renal failure
- Liver failure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac group Cystoscopy The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local Diclofenac group Lubricant Gel The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local Placebo Cystoscopy The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy Placebo Lubricant Gel The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy Diclofenac group Diclofenac Sodium The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
- Primary Outcome Measures
Name Time Method Assesment for operational pain 1 minute All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain.
- Secondary Outcome Measures
Name Time Method Assesment of qualification of cystoscopy 1 minute It is subjective. It will be made by a question which will be answered by blind operator.
The operator will choose one of the answers which are "adequate or not adequate".Assesment of doctors comfort for the procedure(cystoscopy) 1 minute It is subjective, It will made by a question which will be graded by the blind operator.
The operator will choose one of the 5 answers. Scoring system will be range 1 to 5 and higher scores mean worse results.
Trial Locations
- Locations (1)
Medeniyet University
🇹🇷Istanbul, Outside U.S./Canada, Turkey