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临床试验/NCT00943475
NCT00943475已完成4 期

Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children

Federal University of Juiz de Fora2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
local anesthesia relieve the circumcision pain

研究概览

简要总结

The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient.

This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory.

With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 13 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • ASA status physical 1 children between 3 and 13 years old

排除标准

  • parents don't accept the study classic circumcision

结局指标

主要结局

local anesthesia relieve the circumcision pain

时间窗: per-operatory; 1h and 24h pos-operatory

次要结局

  • local anesthesia relieve the circumcision pos-operatory pain(1h and 24h pos-operatory)

研究者

发起方
Federal University of Juiz de Fora
申办方类型
Other

研究点 (2)

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