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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Albany Medical College.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT00574015
First received: December 13, 2007
Last updated: December 19, 2012
Last verified: September 2010
History of Changes
  Purpose

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

Condition Intervention Phase
Toothache
 Drug: hydrocodone/acetaminophen
Drug: bupivacaine (supraperiosteal nerve block)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • VAS determination of pain at 30 minutes following intervention [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric scale report or pain Number of prescribed analgesic pills taken [ Time Frame: 24-36 hours following intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral
administration of oral analgesia
 Drug: hydrocodone/acetaminophen
oral hydrocodone 10 mg/acetaminophen 650 mg
Other Names:
  • Lortab
  • Vicodin
Experimental: Dental Block
Administration of supraperiosteal nerve block to effected tooth
 Drug: bupivacaine (supraperiosteal nerve block)
Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
Other Name: Marcaine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574015

Contacts
Contact: Wayne R Triner, DO, MPH 518-262-3773 trinerw@mail.amc.edu

Locations
United States, New York
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208
Principal Investigator: Wayne R Triner, DO, MPH            
Sponsors and Collaborators
Albany Medical College
Investigators
Principal Investigator: Wayne R Triner, DO, MPH Albany Medical College
  More Information

No publications provided

Responsible Party: Wayne Triner, DO, MPH, Emergency Medicine, Albany Medical College
ClinicalTrials.gov Identifier: NCT00574015     History of Changes
Other Study ID Numbers: 2200, 2200
Study First Received: December 13, 2007
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albany Medical College:
toothache
regional anesthesia
emergency department

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Bupivacaine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Analgesics, Opioid
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 22, 2013