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NCT Number: NCT01812928

Diclofenac Suppository to Control Pain During Flexible Cystoscopy

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.

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Key information

Conditions

Pain Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematuria Hemorrhage Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac

Drug

Other names: Non steroidal anti-inflammatory drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Acronym: DUF

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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