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临床试验/NCT00480519
NCT00480519Unknown3 期

Use of Sedation and Local Anesthesia in Meatotomy: A Prospective Comparison Study

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2007年5月1日最近更新:
适应症

试验速览

阶段
3 期
入组人数
75
试验地点
1
主要终点
pain control, voiding quality

研究概览

简要总结

The aim of the study is to prospectively investigate the feasibility, pain control, and outcome of meatotomy performed under sedation and local anaesthesia compared with general anaesthesia with and without patient block

详细描述

Background- Meatal stenosis requiring surgery occurs more often in circumcised than in uncircumcised boys, with an estimated rate of 7.3%. At our institute, meatotomy is usually performed under general anesthesia and penile block is routinely added after induction. Recently, several reports have described the performance of meatotomy as an office procedure under local anesthesia, with good patient tolerability and a considerable reduction in operative time and costs.

Purpose - The aim of the study is to prospectively investigate the feasibility, pain control, and outcome of meatotomy performed under sedation and local anaesthesia compared with general anaesthesia with and without patient block.

Materials and Methods- The study population will include 75 otherwise healthy boys aged 3 years to 15 years scheduled for meatotomy at our institute. Children with ASA grade >2 will be excluded. The children will be reexamined by a senior pediatric ulologist to confirm the need for surgery. All children and their parents will be given a detailed explanation of the procedure and of the anesthesia and pain control options available by a urology nurse, pediatric urologist, and anesthesist.

Prior to surgery, study participants will be randomly allocated to one of the following groups:

Group 1 will include 25 patients who will undergo meatotomy under sedation and local anesthesia. The penis will be topically treated with EMLA cream one hour before surgery and then covered with tegaderm. In children aged 3-5 years, sedation will consist of midazolam 0.5 mg/kg (up to 10 mgs) p.o., administered 20 minutes before surgery; children aged 5 years and older will receive nitrous oxide (up to 60%) with oxygen. All patients will be connected to a pulse oximeter and monitored by a sedation nurse or an anesthesist.

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

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Boys between 3 years and 18 years with meatal stenosis requiring meatotomy

排除标准

  • •ASA grade > 2

结局指标

主要结局

pain control, voiding quality

时间窗: one month after the procedure

次要结局

  • general satisfaction(before the child is discharged from the hospital, and one month after the procedure)

研究者

申办方类型
Other

研究点 (1)

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