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临床试验/NCT02861378
NCT02861378已完成不适用

Reversing the Effects of 2% Lidocaine: A Randomized Controlled Trial

Dalhousie University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Time to return of normal soft tissue sensation and function

研究概览

简要总结

Dental procedures often require the use of local anesthesia. The effects of the anesthesia usually linger for some time after the dental procedure is completed which can lead to discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal of local anesthesia compared to sham injections. However, no trials have been conducted comparing phentolamine mesylate to a true control injection. Such trials are needed in order to definitively show that it is the phentolamine mesylate itself that is causing the reduction in anesthesia rather than a dilution effect.

The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required to the return of normal soft-tissue sensation and function in participants who had received an inferior alveolar nerve block (using 2% Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control).

The study population will comprise dentistry and dental hygiene students of the second year classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen because these students usually practice dental anesthesia on each other as a part of a course on local anesthesia.

This proposed pilot scale study will be a double-blind controlled trial using parallel groups. As part of their usual anaesthesia course, the dental and dental hygiene students will be practicing their inferior alveolar nerve injections on one another using 2% Lidocaine 1:100,000 epinephrine. Students who decide to participate in the study will be randomly assigned to one of two groups: Group 1 will receive an injection of OraVerse (treatment group), while Group 2 will receive an injection of sterile physiological water (control group). The time required to the return of soft-tissue sensation and function will be assessed using a questionnaire.

详细描述

The research will be conducted at the Dalhousie University Dental Clinic. As part of their anaesthesia clinical course, students enrolled in the second year of the dentistry and dental hygiene programs practice different anesthesia techniques on each other during a planned hands-on training activity. The research study will take place during the same day. Participants who meet the eligibility criteria and consent to participate will be randomly assigned to one of two groups. Following anesthesia obtained as a part of their hands-on training session, subjects allocated to Group 1 will receive 1ml of phentolamine mesylate following anesthesia, while subjects allocated to Group 2 will receive 1ml of sterile physiological water.

Phase 1, Both Groups:

  1. Subjects will be trained to use the Assessment of Anesthesia questionnaire
  2. Following training, subjects will perform baseline assessments of their lip and tongue numbness (should be normal).
  3. Prior to anaesthesia is given, vital signs will be recorded. Blood pressure, respiratory rate and pulse will all be recorded.
  4. Topical anesthetic, 20% benzocaine, will be applied to the injection site for 3 minutes. Subjects will be given a standard inferior alveolar nerve block injection, with aspiration before injection, using 1ml of 2% lidocaine with 1:100,000 epinephrine from the student they are teamed with. This step is not part of the study; it is done as part of their clinical anesthesia course.
  5. Soft tissue anaesthesia will be self-assessed, by using finger tapping and palpation, to ensure profound anesthesia. The second phase (OraVerse or water) will not take place before profound anesthesia has been achieved. The anesthetic outcome will be considered a failure if the participant does not report anesthesia of the lower lip within 10 minutes.
  6. If profound anesthesia is achieved within 10 minutes, subjects will proceed to phase 2. If profound anesthesia is not achieved within 10 minutes subjects will be withdrawn from the study. Subjects who are withdrawn from the study will continue with their standard training protocol which is to receive a re-injection of anesthetic. A withdrawal form will be used by Dr. Flood to record the occurrence of anesthesia failures. This form will also record reasons for withdrawals, should any occur for different reasons.

Phase 2 Group 1: Phentolamine Mesylate After anesthesia is confirmed, subjects in Group 1 will receive an injection of 1ml of a solution containing 0.24mg of phentolamine mesylate in the same site previously injected with anaesthetic solution. Dr. Brittany Flood will give the injection to ensure consistency.

Group 2: Water After anesthesia is confirmed, subjects in Group 2 will receive an injection of 1ml of sterile physiological water in the same site previously injected with anesthetic solution. Dr. Brittany Flood will give the injection to ensure consistency.

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
Triple (Participant, Care Provider, 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

  • Students of the Dalhousie University Dental Clinic who are:
  • Age 18 and over
  • Capable of providing informed consent

排除标准

  • Subjects with a medical history that contraindicates the use of epinephrine.
  • Subjects who have taken an opioid or an opioid-like analgesic within 24 hours of the anesthesia session.
  • Pregnant females

研究组 & 干预措施

Phentolamine mesylate

Experimental

Once anesthesia is confirmed, subjects in the Phentolamine mesylate group will receive 1 injection of 1ml of a solution containing 0.24 mg of phentolamine mesylate in the same site that was previously anaesthetized (not as a part of the study).

干预措施: Phentolamine mesylate (Drug)

Water

Placebo Comparator

Once anaesthesia is confined, the subjects in the water group will receive 1 injection of 1 ml of sterile physiological water in the same site that was previously anaesthetized (not as a part of the study).

干预措施: Water (Drug)

结局指标

主要结局

Time to return of normal soft tissue sensation and function

时间窗: Every 10 minutes, from the injection of reversing agent or placebo until return to normal soft tissue sensation and function (up to 4 hours)

Soft tissue anesthesia will be assessed using the Assessment of Anesthesia questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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