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临床试验/NCT06220175
NCT06220175已完成不适用

Pharynx Analgesia Before Upper Gastrointestinal Endoscopy: a Prospective, Randomized Comparative Trial

Carol Davila University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Patient satisfaction score

研究概览

简要总结

This is a comparative study on patient and endoscopist experience during upper gastrointestinal endoscopy with NSAIDs (flurbiprofen) topical analgesia plus xilocaine spray topical anesthesia of the pharynx versus xilocaine spray topical anesthesia of the pharynx alone, before procedure.

详细描述

Upper gastrointestinal endoscopy may be done with topical anesthesia of the pharynx with xilocaine spray, with conscious sedation with midazolam or with general anesthesia with propofol. In Romania, the endoscopist may only offer topical pharyngeal anesthesia, any other sedation or anesthesia needs the presence of an anesthesiologist on premises.

Xilocaine spray improves the gag reflux and the satisfaction score of the patient as well as the ease of insertion and the satisfaction score of the endoscopist.

A study published in 2010 has compared the tolerance of upper GI endoscopy in patients in which the topical anesthesia of the pharynx has been done using Strepsils Plus with xilocaine versus xilocaine spray. The group of patients with Strepsils Plus had a significantly lower tolerance, lower anesthesia score, a higher gag score and a higher disconfort score versus patients in group with xilocaine spray.

Nevertheless, topical pharyngeal anesthesia with benzocaine spray and in much lesser degree with xilocaine spray may lead to a very rare adverse reaction, namely methemoglobinemia. That is why, an safer alternative to xilocaine spray would be desirable at this moment.

Question at which the research protocol is trying to answer The investigators intent to evaluate whether a topical pharyngeal anti inflammatory molecule, a non steroidal anti inflammatory drug (NSAID), that is Strepsils Intensive with honey and lemon which contains flurbiprofen 8.75mg before upper GI endoscopy plus xilocaine spray improves the satisfaction score of the patient as compared to standard xilocaine spray alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patient with indication of upper gastrointestinal endoscopy with topical pharyngeal anesthesia with xilocaine spray
  • Age above 18 years
  • Informed consent

排除标准

  • Allergy to xilocaine and/or flurbiprofen
  • Absence of informed consent

研究组 & 干预措施

Strepsils Intensiv Arm + Xilocaine Spray

Experimental

Patient will take one pill of Strepsils Intensiv containing 8.75mg flurbiprofen 10 to 15 minutes before endoscopy.

The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.

干预措施: Strepsils Intensiv plus Xilocaine spray Arm (Drug)

Xilocaine Spray Arm

Active Comparator

The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.

干预措施: Xilocaine Spray Arm (Drug)

结局指标

主要结局

Patient satisfaction score

时间窗: 24 hours

Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

次要结局

  • Endoscopist satisfaction score(24 hours)
  • Patient gag score(24 hours)
  • Patient discomfort score(24 hours)
  • Patient pain score(24 hours)

研究者

发起方
Carol Davila University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihai Ciocirlan

Associate Professor of Gastroenterology

Carol Davila University of Medicine and Pharmacy

研究点 (1)

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