Pain Clinical Trial
Official title:
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
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.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | May 22, 2019 |
Est. primary completion date | April 22, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Medeniyet University | Istanbul | Outside U.S./Canada |
Lead Sponsor | Collaborator |
---|---|
Taha Uçar |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assesment for operational pain | 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. | 1 minute | |
Secondary | Assesment of doctors comfort for the procedure(cystoscopy) | 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. |
1 minute | |
Secondary | Assesment of qualification of cystoscopy | 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". |
1 minute |
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