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临床试验/CTRI/2025/07/091087
CTRI/2025/07/091087尚未招募不适用

Comparison of pain perception during intravenous cannulation between EMLA cream and Lidocaine HCL padded dressing in adult patients: A prospective observational study

Sameeksha K Suvarna1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
114
试验地点
1
主要终点
To evaluate the pain intensity experienced by adult patients during intravenous cannulation after application of EMLA Cream

研究概览

简要总结

This study is designed as a prospective observational study. The patient files will be used to

gather demographic information about the patients, such as age, gender. Vital indicators like

oxygen saturation (SpO2) and heart rate (HR) will be monitored during the procedure.

Following IVC, patients in both groups will use the Visual Analog Scale (VAS) and the Verbal

Descriptor Scale (VDS) to rate their level of discomfort. Two subgroups will be created from

the patients using EMLA CREAM and Lidocaine HCL during IVC- a routine procedure done

on the dorsum of the hand (Cephalic vein, basilic vein, dorsal metacarpal vein), will be carried

out by same anaesthesiologist, in the ward and pre-operative settings, each containing 57

participants.

In Group E (EMLA CREAM) the site where IVC is planned will be covered in padded dressing

impregnated with a thick layer of 1 mL (or 1 gram) of EMLA cream and left for 30 minutes.

After 30minutes the padded dressing will be removed and an effort will be made to perform

intravenous cannulation using a suitable gauged cannula by an experienced assigned

anaesthesiologist. In group L (Lidocaine HCL) a padded dressing impregnated with a 10%

lidocaine HCL pump spray solution will be applied to the skin where IVC is planned and left

in place for 30 minutes and cannulation is carried out by an anaesthesiologist while the

principal investigator will be observing and documenting the pain scores. The Visual Analogue

Scale (VAS) scores and VDS scores will be recorded, and hemodynamic parameters will be

monitored during the procedure. Assessing effectiveness typically involves standardized pain

measurement tools like the Verbal Descriptor Scale (VDS) and the Visual Analogue Scale

(VAS). The VDS allows patients to describe pain using terms such as "no pain" or "severe,"

while the VAS uses a 10-centimeter line to quantify pain intensity.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants of all gender aged between 19-60 years
  • Patients requiring intravenous cannulation
  • Only participants with American society of anesthesiologist physical status 1 and 2 are included
  • Patients undergoing elective surgery.

排除标准

  • Patients who are unwilling or opposed
  • Coagulopathy or bleeding disorders
  • A history of allergic reactions to anesthetics.

结局指标

主要结局

To evaluate the pain intensity experienced by adult patients during intravenous cannulation after application of EMLA Cream

时间窗: done in ward and pre-operative setting applied and kept for 30 minutes and after cannulation pain scales are assesed

次要结局

  • o evaluate the pain intensity experienced by adult patients during intravenous cannulation after application of Lidocaine HCL(done in ward and pre-operative setting applied and kept for 30 minutes and after cannulation pain scales are assessed)
  • To compare the pain intensity experienced by adult during intravenous cannulation after application of either EMLA cream or Lidocaine HCL padded dressing(After cannulation and after taking VAS and VDS scale will compare takes less than 5 minutes)

研究者

发起方
Sameeksha K Suvarna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sameeksha K Suvarna

Yenepoya school of allied health sciences

研究点 (1)

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