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临床试验/NCT02750137
NCT02750137已完成不适用

Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop

KK Women's and Children's Hospital0 个研究点目标入组 192 人开始时间: 2014年8月最近更新:
适应症
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
192
主要终点
Incidence of skin reactions with Ametop

研究概览

简要总结

Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be higher compared to other studies. This lead to a prospective observational study to look at the incidence and severity of skin reactions following routine clinical application of Ametop.

详细描述

Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. After several critical incidences of adverse reactions that occurred with its application, a departmental audit was carried out to look at the incidence and severity reactions with its application as well as its outcome on intravenous cannulation. The findings of the departmental audit showed that the incidence of adverse reactions seemed to occur more commonly compared to other studies.

A prospective observational study was carried out to look at the incidence and severity of skin reactions following routine clinical application of Ametop.

This study aims to achieve the following:

  1. Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation
  2. Assess the success rate of intravenous cannulation
  3. Identify the possible risk factors associated with adverse skin reaction.

研究设计

研究类型
Observational
观察模型
Case Only

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation.

排除标准

  • Any patient who did not have Ametop applied or have an intravenous cannula in situ.

结局指标

主要结局

Incidence of skin reactions with Ametop

时间窗: October 2014 to May 2015

looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor

次要结局

  • Risk factors associated with incidence of skin reactions(October 2014 to May 2015)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Angela Tan Yun June

Senior Resident

KK Women's and Children's Hospital

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