Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children and Teenagers
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
- 否
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
group treated
干预措施: Lidocaine (Drug)
2
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)
