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临床试验/NCT03678168
NCT03678168已完成不适用

A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

King Hamad University Hospital, Bahrain2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Comparison of postoperative throat pain using the visual analogue scale (VAS)

研究概览

简要总结

Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.

详细描述

The nose and para nasal sinuses are anatomically known to be highly vascular and a substantial amount of bleeding is expected from rhinology surgeries, ingested blood is known to be a power full emetic, and the risk aspiration of blood is present due to the fact that an endotracheal tube is not 100% effective in protecting the airway. Post-operative nausea and vomiting is a frequent problem that is encountered in surgical patients with a 4th to 6th fold increase in nasal and endoscopic sinus operations.

Posterior throat pack is an often-used in rhinology surgery, it is said to help in protecting the air way against aspiration and also helps in the reduction of post-operative nausea and vomiting, however many studies concluded that posterior throat pack is associated with higher amount of post-operative pain, nausea,, vomiting and in some rare cases even forgotten in the patient leading to mortality. However, despite poor evidence the placement of posterior throat packs is commonly practiced by surgeons and anesthetists because the possible risk of aspiration is worrisome to the latter and the former.

A conventional throat pack consists of gauze, but an alternative practice involves the pharyngeal placement of tampons. In Marais and Prescott posterior pharyngeal placement of tampons is associated with a decrease amount of post-operative throat pain, when compared to conventional gauze throat packs, however they did not compare the incidence of post-operative nausea and vomiting in both groups.

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
Single (Participant)

盲法说明

The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients ( above the age of 18 years)
  • Admitted under Dr. Hiba Al-Reefy
  • Underwent a rhinology procedure that required the use of a throat pack

排除标准

  • Pediatric patients
  • Pt who underwent a procedure without the use of throat packs

研究组 & 干预措施

Control

Other

Standard care (Throat pack) which will be used as a control.

干预措施: Throat Pack (Other)

Intervention

Experimental

Pharyngeal tampons which will be used as a comparator against throat pack.

干预措施: Pharyngeal Tampons (Other)

结局指标

主要结局

Comparison of postoperative throat pain using the visual analogue scale (VAS)

时间窗: 2 years

Evaluation of postoperative pain between pharyngeal tampons and controls using the Visual Analogue scale. A value of 0 is the lowest value and indicates the patient is pain free. And a score of 10 is the maximum value which indicates extreme pain on the scale.

postoperative throat bleed

时间窗: 2 years

Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control

次要结局

  • Postoperative recovery(2 years)

研究者

发起方
King Hamad University Hospital, Bahrain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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