Reversing the Effects of 2% Lidocaine

NCT02861378 | Completed DMC

• 1 other identifier: 2015-3515
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Anaesthesia

Keywords

anaesthesia, dental; lidocaine

Outcome Measures

Primary Outcomes (1)

• Time to return of normal soft tissue sensation and function

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

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

Study Arms (2)

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).

Drug: Phentolamine mesylate

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).

Drug: Water

Interventions

Phentolamine mesylate DRUG

Injection of 1ml at lidocaine injection site

Also known as: OraVerse

Phentolamine mesylate

Water DRUG

Injection of 1ml of physiologic saline water at injection site

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University Faculty of Dentistry

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Publications (1)

• Michaud PL, Flood B, Brillant MS. Reversing the effects of 2% Lidocaine: A randomized controlled clinical trial. J Dent. 2018 May;72:76-79. doi: 10.1016/j.jdent.2018.03.009. Epub 2018 Mar 20.

  PMID: 29571953 DERIVED

Related Links

• Dalhousie University Faculty of Dentistry Web Site

MeSH Terms

Interventions

Phentolamine; Water

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Pierre-Luc Michaud, MSc

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: August 10, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)