Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
研究概览
简要总结
The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective procedure
- •weight over 40 kg
- •American Society of Anesthesiology class I-III
- •first upper GI endoscopy procedure
- •finnish or/and swedish speaking
排除标准
- •amide and/or esther local anaesthetic allergy
- •paraben allergy
- •Child-Pugh grade B/C liver failure
- •renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale )
- •those presenting with swallowing problem
- •chronic pain condition
- •chronic use of pain medication
- •pregnancy
- •lactation
研究组 & 干预措施
Sodium chloride 0.9%
Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
干预措施: Sodium Chloride 0.9% (Drug)
Articaine hydrochloride 1%
Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
干预措施: Anesthetics, Local (Drug)
Articaine hydrochloride 2%
Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
干预措施: Anesthetics, Local (Drug)
结局指标
主要结局
Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
时间窗: 30 minutes after the procedure
次要结局
- Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)(within 30 minutes after the procedure)
- Cumulative consumption of alfentanil during the procedure (mg)(30 minutes after the procedure)
研究者
Mihkel Meinberg
MD
Helsinki University Central Hospital