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临床试验/NCT00585325
NCT00585325已完成不适用

Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Pain During Dressing Change

研究概览

简要总结

Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups.

Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

详细描述

• All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

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
Single (Investigator)

入排标准

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

入选标准

  • all burn service patients with a wound vac

排除标准

  • allergy to lidocaine

研究组 & 干预措施

Instilled 1% Lidocaine

Experimental

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

干预措施: Instilled 1% Lidocaine (Drug)

Instilled Placebo (0.9% Normal Saline)

Placebo Comparator

receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

干预措施: Placebo (0.9% Normal Saline) (Other)

结局指标

主要结局

Pain During Dressing Change

时间窗: During dressing change

A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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