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临床试验/NCT04112160
NCT04112160已完成2 期

Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年6月28日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
125
试验地点
1
主要终点
Number of Participants That Experienced an Injection Complication

研究概览

简要总结

This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.

详细描述

Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert.

Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily.

The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.

排除标准

  • eGFR <50
  • any active or history of peptic ulcer disease or GI bleeding
  • Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis
  • Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin
  • Allergic reaction to NSAIDs
  • Concurrent use of other NSAIDs within 24 hours
  • Pregnancy (ketorolac contraindicated in this population)
  • Recent myocardial infarction (MI)

研究组 & 干预措施

control

Placebo Comparator

normal saline 0.9%

干预措施: normal saline (Drug)

Ketorolac

Active Comparator

30 mg of Ketorolac

干预措施: Ketorolac (Drug)

结局指标

主要结局

Number of Participants That Experienced an Injection Complication

时间窗: Within thirty days post injection.

Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.

Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.

时间窗: Seven days following ureteral stent removal.

Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.

Number of Participants With Unscheduled Return to Clinic or Emergency Room

时间窗: Seven days following ureteral stent removal.

Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.

Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal

时间窗: Twenty-four hours following ureteral stent removal.

Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.

次要结局

  • Average Number of Days the Participant Missed Work(Seven days following stent removal.)
  • Number of Patients That Required Opioid Medication Following Ureteral Stent Removal(Twenty-four hours following stent removal.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Pearle

Professor

University of Texas Southwestern Medical Center

研究点 (1)

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