Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy|
- difference in pain score between two groups [ Time Frame: five minutes after procedure ] [ Designated as safety issue: No ]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.
- Need of additional analgesia after the procedure [ Time Frame: with in an hour after procedure ] [ Designated as safety issue: No ]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.
- adverse effect of diclofenac suppository [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2013|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
No Intervention: Gel only
This group will be given only intraurethral gel during flexible cystoscopy.
Experimental: Diclofenac and Gel
This group will also receive intraurethral gel during cystoscopy but additionally diclofenac suppository will be given per rectally one hour before procedure as preemptive analgesia.
Other Name: Non steroidal anti-inflammatory drug
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812928
|Aga Khan University Hospital|
|Karachi, Sindh, Pakistan, 74800|
|Principal Investigator:||mehwash nadeem, M.B.,B,S||Aga Khan University Hospital|