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临床试验/NCT01546090
NCT01546090已完成4 期

Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
the success rate of the IAN block

研究概览

简要总结

The purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.

详细描述

Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access is begun 15 minutes after completion of the IAN block, and all patients profound lip numbness. Success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • patients with active pain in a mandibular molar
  • prolonged response to cold testing with Endo-Frost cold spray
  • Absence of any periapical radiolucency on radiographs
  • a vital pulp while access cavity preparation
  • ability to understand the use of pain scales.

排除标准

  • patients were having allergy and sensitivity to benzodiazepines
  • pregnant and breast feeding patients
  • patients who had taken sedation within 24 hours before the treatment
  • having pain in more than one mandibular tooth
  • unable to give informed consent

研究组 & 干预措施

alprazolam

Experimental

Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs

干预措施: Alprazolam (Drug)

placebo

Placebo Comparator

placebo capsules were filled with starch

干预措施: placebo (Drug)

结局指标

主要结局

the success rate of the IAN block

时间窗: one hour after administration of alprazolam

次要结局

  • initial pain(one hour after administration of alprazolam)

研究者

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

Masoud Saatchi

Associate Professor of Endodontics

Isfahan University of Medical Sciences

研究点 (1)

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