The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Assesment for operational pain
研究概览
简要总结
The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug.
Parameters:
-
Visual Pain Score during cystoscopy
-
Cystoscopy comfort - a questionnaire to be filled by the doctor
-
Excellent
-
Very good
-
Good
-
Bad
-
Too bad
-
Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
Post-Op:
- 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
- 24th Hour dysuria, Frequency,
A total of 144 patients, we plan to arrive at the end of 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blind placebo controlled
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Accepted to participate
- •18-70 years old
排除标准
- •Previous peptic ulcer
- •Gastro intestinal bleeding in advance
- •Renal failure
- •Liver failure
- •Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies
- •7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study
研究组 & 干预措施
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
干预措施: Diclofenac Sodium (Drug)
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
干预措施: Cystoscopy (Device)
Diclofenac group
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
干预措施: Lubricant Gel (Drug)
Placebo
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
干预措施: Cystoscopy (Device)
Placebo
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
干预措施: Lubricant Gel (Drug)
结局指标
主要结局
Assesment for operational pain
时间窗: 1 minute
All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain.
次要结局
- Assesment of qualification of cystoscopy(1 minute)
- Assesment of doctors comfort for the procedure(cystoscopy)(1 minute)
研究者
Taha Uçar
Resident Doctor
Istanbul Medeniyet University