跳至主要内容
临床试验/NCT06245239
NCT06245239招募中不适用

Using Perfusion Index in Assessment of Postoperative Pain in Children Undergoing Hypospadias Repair Surgery: an Observational Follow up Study.

Assiut University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
65
试验地点
1
主要终点
Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score

研究概览

简要总结

The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.

详细描述

* Hypospadias repair is a common surgery that is accompanied with significant postoperative pain. The largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. Although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae.

That is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible.

* Changes in perfusion index(PI) caused by sympathetic stimulation refers to possible correlation between pain and PI which forms the basis of our study proposing that the PI is a non-invasive easy method that can be used in evaluating pain in infants

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients aged <3 years
  • Sex:- both male and female.
  • Informed written consent obtained from parents or guardians of all patients.
  • Undergoing hypospadias repair surgery

排除标准

  • Patients outside the selective age range
  • Parents or guardians refusing to enroll their child in the study.
  • ASA III or VI
  • Children with behavioral changes or physical developmental delay
  • Children treated with sedatives or anticonvulsants.

结局指标

主要结局

Detection of the validity of Perfusion index in predicting Postoperative pain assessed by FLACC score

时间窗: The baseline preoperative Perfusion index., The FLACC score along with the corresponding Perfusion index readings, will be recorded postoperatively: upon arrival to the PACU and every 30 minutes for 2 hours, then at 6, 12, 18, 24 hours.

The FLACC score along with the corresponding Perfusion index readings

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Yahia Mohammd El-hagagy

lecturer of anesthesia and intensive care, faculty of medicine, Assiut University

Assiut University

研究点 (1)

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