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The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

Primary Purpose

Toothache

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
hydrocodone/acetaminophen
bupivacaine (supraperiosteal nerve block)
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toothache focused on measuring toothache, regional anesthesia, emergency department

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Albany Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oral

Dental Block

Arm Description

administration of oral analgesia

Administration of supraperiosteal nerve block to effected tooth

Outcomes

Primary Outcome Measures

VAS determination of pain at 30 minutes following intervention

Secondary Outcome Measures

Numeric scale report or pain Number of prescribed analgesic pills taken

Full Information

First Posted
December 13, 2007
Last Updated
March 21, 2014
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00574015
Brief Title
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
Official Title
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Background: Toothache is a common complaint among patients presenting to the emergency department. There are two commonly employed methods of alleviating this severe form of pain. Oral opioid analgesia is the most commonly utilized strategy for treating this pain. However, many emergency physicians and dentists employ a local anesthetic technique known as supraperiosteal nerve block. This study will compare the relative efficacy of these techniques. Patients meeting enrollment criteria will be randomized to either receive a supraperiosteal nerve block or oral hydrocodone 10 mg/acetaminophen 650 mg. They will otherwise be managed identically. Reduction of pain scores between entry and 30 minutes post intervention will be compared as well as numeric pain scores obtained by phone contact 24 hours later. Secondary outcomes will include the proportion of individuals from each group filling prescriptions for pain medication and the number of pain pills taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toothache
Keywords
toothache, regional anesthesia, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral
Arm Type
Active Comparator
Arm Description
administration of oral analgesia
Arm Title
Dental Block
Arm Type
Experimental
Arm Description
Administration of supraperiosteal nerve block to effected tooth
Intervention Type
Drug
Intervention Name(s)
hydrocodone/acetaminophen
Other Intervention Name(s)
Lortab, Vicodin
Intervention Description
oral hydrocodone 10 mg/acetaminophen 650 mg
Intervention Type
Drug
Intervention Name(s)
bupivacaine (supraperiosteal nerve block)
Other Intervention Name(s)
Marcaine
Intervention Description
Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
Primary Outcome Measure Information:
Title
VAS determination of pain at 30 minutes following intervention
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Numeric scale report or pain Number of prescribed analgesic pills taken
Time Frame
24-36 hours following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Involvement of a single tooth Percussive tenderness of the crown of the suspect tooth Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne R Triner, DO, MPH
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

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