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临床试验/NCT00521703
NCT00521703已完成3 期

Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers

Hospital Infantil Cândido Fontoura1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
propofol dose required to achieve adequate sedation to upper digestive endoscopy

研究概览

简要总结

There is some controversy in the medical literature regarding the effectiveness of topical lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children, deep sedation and general anesthesia are often used to sedate children submitting to this procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this drug can only be used with an anesthesiologist in Brazil. Its main side effects include hypotension, respiratory depression and local pain. Lidocaine is frequently used as premedication, and the rationale is that lowering patient discomfort could lower the required dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients perceive this medication as uncomfortable. This study aims to compare sedative drug doses between patients who were given either placebo or topical lidocaine.

详细描述

This study is a randomized double-blind placebo-controlled clinical trial.

Primary outcome: propofol doses required to achieve adequate sedation.

Population: children submitting to upper digestive endoscopy, weight > 30 kg and age between 8 and 18 years.

Exclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication to either lidocaine or propofol.

Estimated sample: 160 patients. Placebo: tannic acid 0.5%

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years

排除标准

  • Neurological disorders
  • Psychiatric disorders
  • Specific contra-indication to lidocaine
  • Specific contra-indication to propofol

研究组 & 干预措施

1

Experimental

group treated

干预措施: Lidocaine (Drug)

2

Placebo Comparator

control group

干预措施: Tannic acid (Drug)

结局指标

主要结局

propofol dose required to achieve adequate sedation to upper digestive endoscopy

时间窗: one hour

次要结局

  • incidence of tachycardia (heart rate > 120) during the procedure(one hour)
  • incidence of hypoxemia (SpO2 < 94%) during procedure(one hour)
  • severity of sore throat after the procedure(up to 2 hours)

研究者

发起方
Hospital Infantil Cândido Fontoura
申办方类型
Other

研究点 (1)

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