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

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

Tracking Information

First Submitted Date

April 11, 2022

First Posted Date

April 28, 2022

Last Update Posted Date

April 28, 2022

Actual Study Start Date

March 11, 2022

Estimated Primary Completion Date

March 11, 2025 (Final data collection date for primary outcome measure)

Current 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.

Original Primary Outcome Measures

Same as current

Change History

No Changes Posted

Current 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

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Dental Block for Pain Relief in ED Dental Pain Patients

Official Title

Efficacy of ED Provider-Performed Dental Block for Pain Relief in Patients Presenting With Dental Pain

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.

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 Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Dental Pain

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

195

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

March 11, 2026

Estimated Primary Completion Date

March 11, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

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

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT05351099

Other Study ID Numbers

2021094

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

University of California, San Francisco

Original Responsible Party

Same as current

Current Study Sponsor

University of California, San Francisco

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Brian Chinnock, MD

University of California, San Francisco

PRS Account

University of California, San Francisco

Verification Date

April 2022

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