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临床试验/NCT05338671
NCT05338671已完成4 期

Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment

University of Washington1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年9月29日最近更新:
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
35
试验地点
1
主要终点
Post-operative Pain Level 6 Hours on a Visual Analog Scale

研究概览

简要总结

This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.

详细描述

The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being >18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.

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 (Participant)

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

  • Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
  • ASA I or II
  • >18 years old

排除标准

  • Maxillary or mandibular anterior tooth
  • Diagnosis of pulp necrosis or reversible pulpitis
  • Tooth deemed non-restorable
  • <18 years old
  • ASA III, IV, or V
  • Patients who are contraindicated to take ibuprofen
  • Patients with allergies to any medications being assessed in this study

研究组 & 干预措施

2% Lidocaine 1:100,000 epinephrine

Active Comparator

Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment.

干预措施: Local anesthetic (Drug)

0.5% bupivicaine 1:200,000 epinephrine

Active Comparator

Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment.

干预措施: Local anesthetic (Drug)

结局指标

主要结局

Post-operative Pain Level 6 Hours on a Visual Analog Scale

时间窗: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale

Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.

Post-operative Pain Level 12 Hours on a Visual Analog Scale

时间窗: Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale

Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.

Post-operative Pain Level 24 Hours on a Visual Analog Scale

时间窗: Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale

Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.

Post-operative Pain Level 48 Hours on a Visual Analog Scale

时间窗: Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale

Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.

Post-operative Pain Level 72 Hours on a Visual Analog Scale

时间窗: Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale

Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.

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

Avina Paranjpe

Professor: School of Dentistry

University of Washington

研究点 (1)

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