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

NCT03831321 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-02-05

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Taha Uçar

    lead OTHER

Principal Investigators

  • Asıf Yıldırım · Medeniyet University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-04-22
Completion
2019-05-22
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831321 on ClinicalTrials.gov