Hematuria, Lower Urinary Tract Symptoms, Pain
Conditions
Keywords
Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug
Brief summary
Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria (blood in urine). Pain associated with cystoscopy varies from patient to patient, majority requires local anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of topical anesthesia and duration of cystoscopy are recognized as important factors contributing in severity of pain of which use of intraurethral gel left to individual preference. Various studies are available reporting the pain perception with use of various intraurethral gels. Even the highest level of evidence is unable to resolve the query. With this study the investigators hypothesize that pain perception (recorded in form of pain score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone. With better control of pain the investigators aim to increase patient comfort and compliance which will increase the patient satisfaction rate and early return to work.
Interventions
DRUGDiclofenac
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All male patients aged 18 and above * Visiting for evaluation of Haematuria or * Lower urinary tract symptoms (which include poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence) * For removal of double J ureteral stent will be included in the study.
Exclusion criteria
* Patients with clinical evidence of urethral stricture and/or prostatitis, * Patients in which biopsy will be taken, * those having psychiatric illness, * Asthmatics * Kidney, liver disease * Those allergic to NSAIDs (non-steroidal anti-inflammatory drugs) * Those who refuse to participate, * Having history of chronic analgesia use or * Having language barrier will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in pain score between two groups | five minutes after procedure | Patient under goes the procedure and with in the operating room the outcome assessor(who will be blinded to randomization) will record the pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of additional analgesia after the procedure | with in an hour after procedure | Patient will be assessed for pain during the stay in recovery that usually last for an hour. If there will be need of additional analgesia (if patient reports pain score of more than 7 on visual analogue scale)the type of analgesia, dose and frequency will be noticed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse effect of diclofenac suppository | 1 hour | Diclofenac is safe according to the available literature however minority of patients may have skin itching or difficulty in breathing. Post procedure patient will also be observed for any side effect of diclofenac suppository (if received preoperatively. |
Countries
Pakistan
Outcome results
None listed