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临床试验/NCT03111381
NCT03111381已完成2 期

Toradol to Reduce Ureteroscopic Symptoms Trial

Yale University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
94
试验地点
1
主要终点
Post-operative Pain

研究概览

简要总结

Double blinded randomized controlled clinical trial to assess the impact of intraoperative Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone management.

详细描述

This is an investigator-initiated, single-center, prospective randomized clinical trial evaluating the efficacy of intraoperative Ketorolac on post-operative pain in patients undergoing ureteroscopy at Yale-New Haven Hospital.

The study population will include anyone between the age of 18-80 who is undergoing elective ureteroscopy for management of stone disease without contraindication to ketorolac.

Patients who are being consented to undergo a ureteroscopy with the PI will be asked to participate in this study. There is currently no consensus on standard of care regarding intraoperative analgesia for ureteroscopy. There is wide variability in practice, some clinicians choose to administer intraoperative analgesia while others rely only on the sedation effects of general anesthesia. This study is being carried out to see if administration of Ketorolac during ureteroscopy provides a post-operative benefit in pain scores when compared to no treatment.

The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because participants will be under general anesthesia, participants will not know if they received the medication. Following the procedure, the intervention group may continue to use Ketorolac as needed to manage pain. The only difference between the intervention group and the non-intervention group is the one time dose of intraoperative ketorolac.

The FDA approves Ketorolac as a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing Ureteroscopy for kidney stone management between age 18-80.

排除标准

  • Unable to provide consent
  • Contraindications to Toradol

研究组 & 干预措施

Intervention Group

Experimental

The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents

干预措施: Toradol (Drug)

结局指标

主要结局

Post-operative Pain

时间窗: up to 1 week

Once the patient is at home, they will fill out a validated visual analog pain scale to rate their pain. This will be filled out once a day for a total of 7 days following the procedure. This is total morphine equivalent use. The range is 0 to infinity. Higher scores are equated to worse pain. The units are "ME" or morphine equivalents.

次要结局

  • Number of Participants With Complications(6 weeks post operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Toradol to Reduce Ureteroscopic Symptoms Trial | 临床试验