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临床试验/NCT05957718
NCT05957718已完成不适用

Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial

Uppsala University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年8月2日最近更新:
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
发起方
入组人数
88
试验地点
1
主要终点
Wong-Baker Scale Pain

研究概览

简要总结

Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Therefore, implementing effective pain management strategies during venipuncture is crucial to ensure patient comfort and improve the overall healthcare experience. This comprehensive overview aims to highlight the significance of pain management during venipuncture procedures.

This study will investigate the effects of a pharmacological approach on the pain that children experience during venipuncture in a randomized trial.

TKTX topical anesthetic cream is a new commercially available product. In this study, the cream will be used for a shorter period of time than other creams used in previous studies, and it will also be free of side effects as they have been in previous studies with other creams.

详细描述

Venipuncture is a common medical procedure involving the insertion of a needle into a vein, often causing discomfort and pain. To alleviate this pain, pharmacological approaches have been widely explored. The efficacy of these approaches in managing venipuncture-related pain is of utmost importance for both healthcare professionals and patients. Various pharmacological options have been studied, including topical anesthetics such as lidocaine creams or patches, local anesthetic injections like buffered lidocaine or ethyl chloride spray, and systemic analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.

You may experience some pain, often a brief sting, when the needle is inserted into and removed from your arm.

Non-pharmacological pain intervention is a prophylactic and complementary approach to reduce pain.

Ensuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance.

Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA (r), amethocaine and lidocaine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School-age Children and
  • Required needle procedures

排除标准

  • Neurodevelopmental problems
  • Chronic disease
  • Taken Analgesic

研究组 & 干预措施

TKTX Group

Experimental

In this group, We will use TKTX cream as a local anesthesia

干预措施: TKTX cream (Drug)

Control Group

Placebo Comparator

In this group, we will use a Vasalin as Placebo

干预措施: TKTX cream (Drug)

结局指标

主要结局

Wong-Baker Scale Pain

时间窗: 2-3 min. after procedure

Was used to measure Children's pain scale

次要结局

  • Child Fear Scale(2-3 min. after procedure)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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