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Clinical Trials/NCT05351099
NCT05351099RecruitingNot Applicable

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

University of California, San Francisco1 site in 1 country195 target enrollmentStarted: March 11, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
195
Locations
1
Primary Endpoint
Change in Pain Scores on the Visual Analog Scale (VAS)

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Percentage of patients who would have procedure done again(10 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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