The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Overview
- Phase
- Phase 4
- Intervention
- Diclofenac Sodium
- Conditions
- Bladder Cancer
- Sponsor
- Taha Uçar
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Assesment for operational pain
- Last Updated
- 7 years ago
Overview
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:
-
Visual Pain Score during cystoscopy
-
Cystoscopy comfort - a questionnaire to be filled by the doctor
- Excellent
- Very good
- Good
- Bad
- Too bad
-
Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
Post-Op:
- 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
- 24th Hour dysuria, Frequency,
A total of 144 patients, we plan to arrive at the end of 1 month.
Investigators
Taha Uçar
Resident Doctor
Istanbul Medeniyet University
Eligibility Criteria
Inclusion Criteria
- •Accepted to participate
- •18-70 years old
Exclusion Criteria
- •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
Arms & Interventions
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
Intervention: Diclofenac Sodium
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
Intervention: Cystoscopy
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
Intervention: Lubricant Gel
Placebo
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
Intervention: Cystoscopy
Placebo
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
Intervention: Lubricant Gel
Outcomes
Primary Outcomes
Assesment for operational pain
Time Frame: 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 Outcomes
- Assesment of qualification of cystoscopy(1 minute)
- Assesment of doctors comfort for the procedure(cystoscopy)(1 minute)