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临床试验/NCT07421622
NCT07421622尚未招募不适用

A Pilot Randomized Controlled Trial in Management of Epistaxis Comparing Nasal Packing Versus Greater Palatine Foramen Block

Sheikh Zayed Federal Postgraduate Medical Institute0 个研究点目标入组 40 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
● Pain intensity measured

研究概览

简要总结

The goal of this pilot randomized controlled trial is to compare pain relief efficacy while using nasal packing versus greater palatine foramen block (GPFB) in the management of acute episodes of epistaxis. The main questions it aims to answer are: Does GPFB have less potential to inflict pain when dealing with hemostasis with epistaxis, utilizing a pre-validated 10-point visual analog scale (VAS)? Was hemostasis management more effective in either technique? Researchers will compare anterior nasal packing to greater palatine foramen block using 2% xylocaine with adrenaline.

Patients will receive any of the hemostatic interventions at the time of the acute epistaxis episode.

The questionnaire will be administered 24 hours post-intervention.

详细描述

Introduction:

The most common otorhinolaryngological emergency in primary care and emergency departments is epistaxis, which commonly causes severe anxiety in both patients and medical professionals. It shows a bimodal age distribution, with adults between the ages of 50 and 70 and children between the ages of 2 and 10 showing a higher occurrence. Nearly 6% of the general population needs medical attention, and about 60% of people have at least one episode of epistaxis in their lives. Because of its unpredictable clinical course, epistaxis can range in intensity from moderate, self-limiting episodes to severe hemorrhage, and in some situations, it may be deemed life-threatening.

The nasal cavity is vascularized by an extensive anastomotic circuit composed of branches from both the internal and external carotid arteries. The anterior nasal septum is supplied by the anterior and posterior ethmoidal arteries, the sphenopalatine, greater palatine, and superior labial arteries. These blood vessels create Kiesselbach's plexus, which is the most common source of anterior epistaxis. The sphenopalatine artery and terminal branches of the maxillary artery, which are commonly associated with posterior epistaxis, they nourish the posterior part of nasal septum and lateral nasal wall, respectively.

Managing epistaxis has been a major problem in otolaryngology for a long time. This nasal hemorrhagic condition can be attributed to various reasons, including trauma, localized nasal pathology, hematological disorders, systemic hypertension, anticoagulant therapy, and endoscopic sinus surgery. Despite the availability of many therapy modalities, a subset of patients develops epistaxis that is resistant to standard treatment, necessitating more advanced treatment techniques.

An accepted treatment for epistaxis that has not responded to initial hemostatic methods like pressure or cautery is nasal packing. Bismuth iodoform paraffin paste (BIPP) on ribbon gauze is among the most often used packaging materials. To efficiently pack the nasal cavity with BIPP, a certain level of anatomical expertise is required while utilizing a head light, the equipments, and packing the nasal cavity. Over the last three decades, merocel nasal packs have evolved the practise and are routinely used replacing the BIPP nasal packing for controlling epistaxis that failed initial hemostasis measures. The efficacy of Merocel packs in controlling bleeding has been marked as 91.5 % in the literature. Use of the correct insertion technique is very important. Both of these techniques have equivalent effectiveness to stop bleeding and there was no significant difference in efficacy or patient tolerance of either treatment. Such nasal packing techniques have a large learning curve during insertion. Moreover, the discomfort whilst in situ and on removal is non-negotiable.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presentation with active anterior epistaxis
  • Failure of initial conservative measures (e.g., nasal compression and topical vasoconstrictors)
  • Ability to provide informed consent and those who consent for the study.

排除标准

  • Suspected or confirmed posterior epistaxis
  • Known bleeding disorders or platelet count <50,000/mm³
  • Use of anticoagulants with supratherapeutic INR
  • Known allergy to local anaesthetic agents

研究组 & 干预措施

Anterior Nasal Packing

Active Comparator

Patients receiving anterior nasal packing for acture epistaxis

干预措施: Anterior Nasal Packing (Procedure)

Greater Palatine Foramen Block (GPFB)

Active Comparator

Patients receiving GPFB to achive hemostasis in acute epistaxis

干预措施: Greater Palatine Foramen Block with 2% xylocaine with adrenaline (Procedure)

结局指标

主要结局

● Pain intensity measured

时间窗: 24 hours post intervention

using the 10-point Visual Analog Scale (VAS) for the interventions mentioned

次要结局

  • ● Successful control of epistaxis(24 hours post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tahira Shaukat

Clinical Professor Head of Otolaryngology & Head and Neck Surgery

Sheikh Zayed Federal Postgraduate Medical Institute

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