Dental Block for Pain Relief in ED Dental Pain Patients

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ClinicalTrials.gov Identifier: NCT05351099

Recruitment Status : Recruiting

First Posted : April 28, 2022

Last Update Posted : April 28, 2022

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Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

Study Description

Brief Summary:

This will be a prospective, observational cohort study assessing immediate pain relief from dental block in ED patients presenting with dental pain. The study will be conducted in the Community Regional Medical Center ED. The aim of this study, then, is to prospectively determine if dental block provides minimal clinically important difference in pain relief to these patients.

Condition or disease
Dental Pain

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Detailed Description:

Patients will be provided written and verbal information about the study. If the patient does not agree to be enrolled in the study at that time, the patient will be asked to give the reason for refusing enrollment. The answer will be recorded without patient identifiers.

Dental blocks will be done by EM faculty or residents, physician assistants, and nurse practitioners who are not necessarily study personnel as dental block is routinely done in the ED as standard of care. Dental block will not be performed by medical students or off-service rotating residents.

Currently, providers are asked to undergo a short training session on how to administer a dental block. The training covers:

Each type of nerve block and indication
Equipment
Safety
Methods to prevent intra-arterial injection
Methods to prevent nerve injury

The education session participation will be tracked by Qualtrics.

Study protocol

Patient identified as potential enrollee
Research associate will examine the track board to see if "Dental Pain" or other dental complaint is listed for the patient. Research associate will then discuss with the practitioner responsible for the patient whether the patient is a candidate for the study.
Practitioners may also identify a patient appropriate for the study and inform the research associate
Research personnel works with the Practitioner evaluating patient and asks practitioner questions regarding the inclusion and exclusion criteria
If patient meets inclusion criteria and has no exclusion criteria, the research personnel will have the practitioner sign the "Inclusion/Exclusion Criteria" form attesting to this
If there are exclusion criteria, this is noted on the "Inclusion/Exclusion Criteria" form (with no patient identifying information) and paper is put in the research file
The provider will then ask the patient's permission to be approached about the study before the research associate approaches the patient
Research personnel discusses the study with the patient
Gives brief intro about the study and its purpose using the Study Participant Information Sheet and gets verbal consent to proceed
If patient refuses to be in the study, the research personnel asks the patient if he/she would be willing to fill out the "Reasons that patient meeting inclusion criteria is refusing enrollment" questionnaire, which is at the bottom of the "Inclusion/Exclusion Criteria" form
Research personnel completes the "Patient characteristics" form with the help of the practitioner and the patient.
The form records demographics, physical/history features, and initial pain VAS
Research personnel completes the "Dental Block Procedure Form" and uses it as a guide for the dental block procedure
The ED practitioner performs the dental block
Standardized equipment will be the following
3-ml syringe
Standard 27-gauge needle
Standardized local anesthetic: Bupivacaine 0.5%
Standardized initial anesthetic amount for each anatomic location
Inferior alveolar: 3 mL
Posterior superior alveolar: 3 mL
Supraperiosteal: 2 mL
Research personnel starts the 10-minute clock with the administration of the dental block
After 10 minutes, research personnel records the pain VAS for the patient on the Dental Block Procedure form
If the practitioner feels that the local anesthetic effect is not sufficient, that practitioner may give further anesthetic as needed
The practitioner will still use the standardized equipment and local anesthetic
Research personnel starts the 10-minute clock
After 10 minutes, research personnel records the pain VAS for the patient on the "Dental Block Procedure" form
Repeat this procedure as needed if the practitioner feels another dental block injection is necessary
If repeated, this is noted on the form and pain VAS is listed again
When the practitioner has made the decision to not give any further dental injection
Research personnel, in consultation with the practitioner, completes the "Dental Block Procedure" form
Research personnel has patient fill out the portion on the "Dental Block Procedure" form that asks:
Would you have dental block procedure done again?

Study Design

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Study Type :	Observational
Estimated Enrollment :	195 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Efficacy of ED Provider-Performed Dental Block for Pain Relief in Patients Presenting With Dental Pain
Actual Study Start Date :	March 11, 2022
Estimated Primary Completion Date :	March 11, 2025
Estimated Study Completion Date :	March 11, 2026

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Change in Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: Baseline10 minutes ]
Pre and Post Procedure Pain Scores will be measured on a VAS line comparing pre and post measurements from left to right. Left side indicating no pain all the way to the right indicating a pain score of 10.

Secondary Outcome Measures :

Percentage of patients who would have procedure done again [ Time Frame: 10 minutes ]
Follow-up survey to determine if patient would have the procedure done again

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients (aged 18-years or older) presenting to the ED with dental pain in whom the ED practitioner plans to perform a dental nerve block will be enrolled. Enrollment will occur 24 hours a day during all days of the week. Patients meeting eligibility criteria will be assessed for inclusion/exclusion criteria. There will be 195 patients enrolled in the study.

Criteria

Inclusion Criteria:

Adult patients (>= 18-years-old) presenting to Community Regional Medical Center emergency department with a complaint of dental pain in whom the ED practitioner plans to perform a dental nerve block

Exclusion Criteria:

Patient with previous dental block within 24 hours prior to arrival at the ED
Refusal of dental block
Patient in law enforcement custody
Patient unable to be properly informed of study purpose or able to complete pain VAS score due to physical/ mental condition (altered mental status, unstable psychiatric patient)
Patient unable to be properly informed of study purpose or able to complete pain VAS score due to language barrier (not English- or Spanish-speaking)
Patient with other acute non-dental painful condition making evaluation of dental pain severity vs non-dental pain severity not possible
Patient with pain in multiple areas of mouth needing dental block in > 1 anatomic area
Patient to have Dental / OMFS ED consult for procedure

Contacts and Locations

Information from the National Library of Medicine

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): NCT05351099

Contacts

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Contact: Brian Chinnock, MD	559-499-6440	brian.chinnock@ucsf.edu
Contact: Jannet Castaneda, BA	559-994-5893	jannet.castanedasanchez@ucsf.edu

Locations

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United States, California
Community Regional Trauma and Burn Center	Recruiting
Fresno, California, United States, 93721
Contact: Brian Chinnock, MD 559-499-6400 brian.chinnock@ucsf.edu
Contact: Jannet Castaneda, BA 559-499-6435 jannet.castanedasanchez@ucsf.edu
Principal Investigator: Brian Chinnock, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

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Principal Investigator:	Brian Chinnock, MD	University of California, San Francisco

More Information

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Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT05351099
Other Study ID Numbers:	2021094
First Posted:	April 28, 2022 Key Record Dates
Last Update Posted:	April 28, 2022
Last Verified:	April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University of California, San Francisco:


Dental Block Inferior alveolar nerve block Posterior superior alveolar nerve block supraperiosteal nerve block

Additional relevant MeSH terms:

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Toothache Tooth Diseases Stomatognathic Diseases	Facial Pain Pain Neurologic Manifestations

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