NCT00574015

Brief Summary

This study will compare the degree of pain control provided by two techniques for persons with toothache in an emergency department. The two techniques include;

  • standard oral narcotic pain medication
  • numbing the tooth with local anesthetic by needle injection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 24, 2014

Status Verified

September 1, 2010

Enrollment Period

5.1 years

First QC Date

December 13, 2007

Last Update Submit

March 21, 2014

Conditions

Toothache

Keywords

toothacheregional anesthesiaemergency department

Outcome Measures

Primary Outcomes (1)

  • VAS determination of pain at 30 minutes following intervention

    30 minutes

Secondary Outcomes (1)

  • Numeric scale report or pain Number of prescribed analgesic pills taken

    24-36 hours following intervention

Study Arms (2)

oral

ACTIVE COMPARATOR

administration of oral analgesia

Drug: hydrocodone/acetaminophen

Dental Block

EXPERIMENTAL

Administration of supraperiosteal nerve block to effected tooth

Drug: bupivacaine (supraperiosteal nerve block)

Interventions

hydrocodone/acetaminophenDRUG

oral hydrocodone 10 mg/acetaminophen 650 mg

Also known as: Lortab, Vicodin
oral
bupivacaine (supraperiosteal nerve block)DRUG

Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root

Also known as: Marcaine
Dental Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Involvement of a single tooth
  • Percussive tenderness of the crown of the suspect tooth

You may not qualify if:

  • Age younger than 18 years
  • Women who are breast feeding
  • Allergy or intolerance to hydrocodone, bupivacaine or acetaminophen
  • Pregnancy
  • Involvement of multiple teeth
  • Pain resulting from pericoronitis.
  • Pain resulting from dental trauma occurring less than 90 days prior
  • Pain of more than 96 hours duration
  • Facial or neck swelling or tenderness
  • Alteration in phonation
  • Cognitive impairment
  • Concurrent use of opiate analgesics
  • Impairment of liver function
  • Consumption of more than 4 grams of acetaminophen in the past 24 hours.
  • Patients who are visually impaired.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center Hospital

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

ToothacheEmergencies

Interventions

oxycodone-acetaminophenacetaminophen, hydrocodone drug combinationBupivacaine

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Wayne R Triner, DO, MPH

    Albany Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emergency Medicine

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

December 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 24, 2014

Record last verified: 2010-09

Locations

US(1)