Reversing the Effects of 2% Lidocaine
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|ClinicalTrials.gov Identifier: NCT02861378|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Anaesthesia||Drug: Phentolamine mesylate Drug: Water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Reversing the Effects of 2% Lidocaine: A Randomized Controlled Trial|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Phentolamine mesylate
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).
Drug: Phentolamine mesylate
Injection of 1ml at lidocaine injection site
Other Name: OraVerse
Placebo Comparator: Water
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).
Injection of 1ml of physiologic saline water at injection site
- Time to return of normal soft tissue sensation and function [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861378
|Canada, Nova Scotia|
|Dalhousie University Faculty of Dentistry|
|Halifax, Nova Scotia, Canada, B3H 4R2|
|Principal Investigator:||Pierre-Luc Michaud, MSc||Dalhousie University|