Comparison of Buffered vs. Non-Buffered Lidocaine Used in Dental and Oral Surgical Procedures: Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Lidocaine Blood Levels 30 Minutes Post Injection
研究概览
简要总结
Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral injection reduces time of onset, results in a deeper anesthetic effect, without the "sting" with injection from a low pH. Additional data are needed to establish clinical important outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug combination.
Clinical pilot studies are proposed as the start of a series of investigations to support or modify the use of the buffered anesthetic for intraoral procedures.
详细描述
Specific Aims:
Compare blood levels at 30min post injection mandibular block with buffered and non- buffered 2% lidocaine with 1/100k epinephrine. Assess outcomes (pain levels during and post-injection, and onset of anesthesia symptoms) after buffered and non-buffered oral administration of 2% lidocaine with 1/100k epinephrine. Assess possible topical anesthetic properties of buffered and non-buffered oral administration of 2% lidocaine with 1/100k epinephrine
Hypotheses:
No difference in peak blood levels exist between buffered and non-buffered intraoral injection of 2% lidocaine with 1/100k epinephrine.
Injection of buffered local anesthetic will produce less discomfort for the subject as compared to the drug with a low pH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-30 years
- •Willingness to complete QOL instrument
- •Willingness to participate in two sessions
排除标准
- •Allergy to lidocaine class of anesthetic drugs
- •Local anesthetic drug use in past week
- •Current symptoms teeth or oral mucosa
研究组 & 干预措施
Buffered Lidocaine
In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block.
Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels
干预措施: Lidocaine (Drug)
Non-buffered Lidocaine
In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block. At least a week later injections would involve the alternate local anesthetic combination.
Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels
干预措施: Lidocaine (Drug)
结局指标
主要结局
Lidocaine Blood Levels 30 Minutes Post Injection
时间窗: 30 minutes post injection
Lidocaine blood levels were obtained 30 minutes post injection micro g/L The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon rank sum tests with Proc NPAR1WAY (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.
次要结局
- Pain Intensity Scores(Immediately after lidocaine injection)
- Number of Minutes to Anesthesia Symptoms of Lower Lip(Patient report of anesthesia symptom onset following injection)
- Topical Anesthesia Effect Contralateral Lower Lip(At time of administration)