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Trial record 47 of 452 for:    DICLOFENAC

Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01812928
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):
Dr.Mehwash Nadeem, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Pain Hematuria Lower Urinary Tract Symptoms Drug: Diclofenac Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Diclofenac
Other Name: Non steroidal anti-inflammatory drug

Primary Outcome Measures :
  1. difference in pain score between two groups [ Time Frame: 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 Outcome Measures :
  1. Need of additional analgesia after the procedure [ Time Frame: 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 Outcome Measures:
  1. adverse effect of diclofenac suppository [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01812928

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Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
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Principal Investigator: mehwash nadeem, M.B.,B,S Aga Khan University Hospital


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Responsible Party: Dr.Mehwash Nadeem, Resident, Aga Khan University Identifier: NCT01812928     History of Changes
Other Study ID Numbers: 122010SUR
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Dr.Mehwash Nadeem, Aga Khan University:
Flexible Cystoscopy
Pain control
Non steroidal anti inflammatory drug
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action