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The Use of Intranasal Ketoralac for Pain Management (Sprix)

2020年2月3日 更新者:Singh Nair、Montefiore Medical Center

Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study

Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.

研究概览

详细说明

The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.

URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.

Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.

The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.

研究类型

介入性

注册 (实际的)

50

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Bronx、New York、美国、10461
        • Montefiore Medical Center- Weiler Division

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ureteroscopic stone removal surgeries with stenting
  • Age ≥ 18 years and < 65 years
  • Stable patient with stable vital signs
  • Mentally competent and is able to understand consent form

Exclusion Criteria:

  • Unstable patients
  • Patients with multiple trauma sites
  • Patients with allergies to ketorolac or any of the components in the nasal spray preparation
  • Patients with active peptic ulcer disease
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • Renal disease or at risk for renal failure due to volume depletion
  • Pregnant or nursing mothers
  • Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)
  • Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intranasal Ketoralac
A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.
15.75 mg of Sprix in each nostril 20 minutes before end of surgery
其他名称:
  • 斯普利克斯
安慰剂比较:Placebo
A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.
15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-operative Opioid Requirements
大体时间:3 hours after surgery
this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.
3 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Post Operative Pain Score
大体时间:30 minutes after surgery
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
30 minutes after surgery
Post Operative Pain Score
大体时间:1 hour after surgery
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
1 hour after surgery
Post Operative Pain Scale
大体时间:2 hours after surgery
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
2 hours after surgery

其他结果措施

结果测量
措施说明
大体时间
Incidence of Postoperative Side Effects
大体时间:24 hours after procedure
To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
24 hours after procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Singh Nair, MD、Montefiore Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2012年11月26日

首先提交符合 QC 标准的

2012年11月28日

首次发布 (估计)

2012年11月29日

研究记录更新

最后更新发布 (实际的)

2020年2月13日

上次提交的符合 QC 标准的更新

2020年2月3日

最后验证

2020年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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