Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- difference in pain score between two groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Diclofenac (Drug)
结局指标
主要结局
difference in pain score between two groups
时间窗: 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.
次要结局
- Need of additional analgesia after the procedure(with in an hour after procedure)
研究者
Dr.Mehwash Nadeem
Resident
Aga Khan University