Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Pain Clinical Trial

— DUF  

Official title:

Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812928
• Other study ID #: 122010SUR
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2013
• Last updated: December 14, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematuria
• Lower Urinary Tract Symptoms
• Pain

Intervention

Drug:
• Diclofenac

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse effect of diclofenac suppository	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.	1 hour	Yes
Primary	difference in pain score between two groups	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.	five minutes after procedure	No
Secondary	Need of additional analgesia after the 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.	with in an hour after procedure	No