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临床试验/NCT04421599
NCT04421599Unknown不适用

Investigation of the Necessity of Aspiration During The Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain

Ege University1 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
834
试验地点
1
主要终点
Individual Introductory Information Form

研究概览

简要总结

H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.

H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.

H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who came to the Emergency Service Care Unit for "Diclofenac Sodium" injection
  • Have no vision and hearing problems,
  • Who have no disease that may affect their perception of pain
  • Who can evaluate the "Visual Analog Scale" correctly, scoring 5 points or less from the VAS,
  • Body Mass Index is between 18.5-24.9 kg / m2,
  • Who do not have any discomfort in the extremities that will prevent them from taking the desired position,
  • No complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region
  • No nodules or masses in the area

排除标准

  • Patients who refuse the injection are excluded.

结局指标

主要结局

Individual Introductory Information Form

时间窗: 15 minutes

The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the "Individual Introductory Information Form" of the patients. Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.

Visual Analog Scale (VAS)

时间窗: 5 minutes

Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to. A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.

次要结局

未报告次要终点

研究者

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

Leyla BARAN

Dr.

Ege University

研究点 (1)

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Necessity of Aspiration in the Ventrogluteal Site | 临床试验