THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments
研究概览
简要总结
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.
详细描述
This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery.
Hypothesis and Aims:
We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a Foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo.
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.
排除标准
- •Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).
- •Known contraindications to phenazopyridine HCl:
- •Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease).
- •History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
- •Known glucose-6-phosphate dehydrogenase deficiency.
- •Simultaneous suprapubic catheterization.
- •Inability to take oral medication within 12 hours after surgery.
- •Pregnant women.
研究组 & 干预措施
Study Medication Group
Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
干预措施: phenazopyridine HCl (Drug)
Placebo tablet Group
For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments
时间窗: 24 hours
The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.
次要结局
未报告次要终点
研究者
Linda Brubaker
Professor of Medicine and Dean and Chief Diversity Officer, Stritch School of Medicine
Loyola University