临床试验/NCT00552695

NCT00552695已完成2 期

Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.

Stony Brook University1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2007年8月1日最近更新: 2012年10月22日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Stony Brook University
入组人数: 45
试验地点: 1
主要终点: Pain on Visual Analog Scale (VAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.

详细描述

Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.

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: Double (Participant, Care Provider)

入排标准

年龄范围: 3 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age greater than or equal to 3,
•Need for non-emergent intravenous catheter

排除标准

•Unstable patients,
•Allergy to lidocaine or tetracaine

研究组 & 干预措施

1

Active Comparator

Lidocaine 70 mg/tetracaine 70 mg skin patch

干预措施: Lidocaine tetracaine (Device)

2

Placebo Comparator

干预措施: Placebo (Device)

结局指标

主要结局

Pain on Visual Analog Scale (VAS)

时间窗: 0 MINUTES

Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).

次要结局

Success of Intravenous (IV) Insertion(After first attempt of catheter insertion)

研究者

发起方

Stony Brook University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Adam Singer

Research Director

Stony Brook University

研究点 (1)

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