The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache - Full Text View

Sponsor:	Albany Medical College
Information provided by:	Albany Medical College
ClinicalTrials.gov Identifier:	NCT00574015

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 IV

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:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Acetaminophen CT 2584 Vicodin Hydrocodone Hydrocodone bitartrate Hycodan

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:	September 30, 2010
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 February 09, 2012