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临床试验/NCT02226913
NCT02226913已完成3 期

Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study

Masoud Saatchi0 个研究点目标入组 80 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
80
主要终点
Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block

研究概览

简要总结

Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control. The purpose of this prospective, randomized, double-blind study was to evaluate the effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

详细描述

Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and improve success rate of anesthesia. There are no studies evaluating a sodium bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible pulpitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

排除标准

  • younger than 18 years old
  • history of significant medical conditions
  • allergies to local anesthetics or sulfites
  • pregnancy
  • taking any medications that might influence anesthetic assessment
  • active sites of pathosis in area of injection
  • inability to give informed consent

研究组 & 干预措施

lidocaine & sodium bicarbonate

Experimental

2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate

干预措施: sodium bicarbonate (Drug)

lidocaine & placebo

Active Comparator

2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water

干预措施: placebo (Drug)

结局指标

主要结局

Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block

时间窗: Baseline

次要结局

  • Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block(Baseline)

研究者

发起方
Masoud Saatchi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Masoud Saatchi

associate professor

Isfahan University of Medical Sciences

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