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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574015
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : March 24, 2014
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
Study Start Date : December 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. VAS determination of pain at 30 minutes following intervention [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Numeric scale report or pain Number of prescribed analgesic pills taken [ Time Frame: 24-36 hours following intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574015

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United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
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Principal Investigator: Wayne R Triner, DO, MPH Albany Medical College
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Responsible Party: Wayne Triner, Professor Emergency Medicine, Albany Medical College Identifier: NCT00574015    
Other Study ID Numbers: 2200
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: September 2010
Keywords provided by Wayne Triner, Albany Medical College:
regional anesthesia
emergency department
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Acetaminophen, hydrocodone drug combination
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics, Opioid
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents