Diclofenac Suppository to Control Pain During Flexible Cystoscopy
NCT ID: NCT01812928
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-03-31
2013-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gel only
This group will be given only intraurethral gel during flexible cystoscopy.
No interventions assigned to this group
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.
Diclofenac
Interventions
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Diclofenac
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
Yes
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Dr.Mehwash Nadeem
Resident
Principal Investigators
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mehwash nadeem, M.B.,B,S
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Locations
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Aga Khan University Hospital
Karachi, Sindh, Pakistan
Countries
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References
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Kobayashi T, Nishizawa K, Mitsumori K, Ogura K. Instillation of anesthetic gel is no longer necessary in the era of flexible cystoscopy: a crossover study. J Endourol. 2004 Jun;18(5):483-6. doi: 10.1089/0892779041271535.
Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4.
Herr HW, Schneider M. Immediate versus delayed outpatient flexible cystoscopy: final report of a randomized study. Can J Urol. 2001 Dec;8(6):1406-8.
Tzortzis V, Gravas S, Melekos MM, de la Rosette JJ. Intraurethral lubricants: a critical literature review and recommendations. J Endourol. 2009 May;23(5):821-6. doi: 10.1089/end.2008.0650.
Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
Komiya A, Endo T, Kobayashi M, Kim W, Araki K, Naya Y, Suzuki H, Tobe T, Ichikawa T, Fuse H. Oral analgesia by non-steroidal anti-inflammatory drug zaltoprofen to manage cystoscopy-related pain: a prospective study. Int J Urol. 2009 Nov;16(11):874-80. doi: 10.1111/j.1442-2042.2009.02384.x. Epub 2009 Sep 24.
Idkaidek NM, Amidon GL, Smith DE, Najib NM, Hassan MM. Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting using NONMEM. Biopharm Drug Dispos. 1998 Apr;19(3):169-74. doi: 10.1002/(sici)1099-081x(199804)19:33.0.co;2-c.
Other Identifiers
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122010SUR
Identifier Type: -
Identifier Source: org_study_id