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临床试验/NCT04426409
NCT04426409已完成不适用

Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年7月8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
108
试验地点
1
主要终点
incidence of epistaxis

研究概览

简要总结

Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.

In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.

The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists physical statue I or II
  • •Patients scheduled to undergo surgery under nasotracheal intubation

排除标准

  • •expected difficult intubation based on history, physical examination, weight.
  • •bleeding tendency
  • •upper respiratory infection within the previous 14 days

研究组 & 干预措施

ointment group

Experimental

Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery.

干预措施: tarivid ointment (Drug)

结局指标

主要结局

incidence of epistaxis

时间窗: immediate after extubation

percentage of the development of epistaxis after nasotracheal intubation

次要结局

  • Navigability(immediate after intubation)
  • severity of epistaxis(immediate after extubation)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

yun jeong chae

Professor

Ajou University School of Medicine

研究点 (1)

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