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临床试验/NCT04473820
NCT04473820已完成3 期

Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
77
试验地点
1
主要终点
Cannulation pain: numerical rating score (NRS)

研究概览

简要总结

Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.

详细描述

Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.

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
None

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

  • Low acute patients who are waiting for the admission to the ED and require IV cannulation

排除标准

  • Altered mental status
  • Uncooperative patients
  • Unable to communicate
  • Known history of hypersensitivity reaction to cold or amid analgesics
  • Analgesic usage in previous 6 hours
  • No consent
  • Emergent condition
  • Pregnancy and lactation

研究组 & 干预措施

Vapocoolant spray

Active Comparator

Patients in this arm will receive vapocoolant spray before IV cannulation.

干预措施: Vapocoolant spray (Drug)

Lidocaine-Prilocaine cream

Active Comparator

Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.

干预措施: Lidocaine-Prilocaine cream (Drug)

结局指标

主要结局

Cannulation pain: numerical rating score (NRS)

时间窗: immediately after the procedure.

The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.

次要结局

  • Application pain: numerical rating score (NRS)(immediately after the procedure.)
  • Catheterization attempts(immediately after the procedure.)

研究者

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

Hadi Mirfazaelian

Assistant Professor of Emergency Medicine

Tehran University of Medical Sciences

研究点 (1)

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