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

NCT ID: NCT00574015

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-01-31

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.

Conditions

Toothache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oral

administration of oral analgesia

Group Type: ACTIVE_COMPARATOR

hydrocodone/acetaminophen

Intervention Type: DRUG

oral hydrocodone 10 mg/acetaminophen 650 mg

Dental Block

Administration of supraperiosteal nerve block to effected tooth

Group Type: EXPERIMENTAL

bupivacaine (supraperiosteal nerve block)

Intervention Type: DRUG

Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root

Interventions

hydrocodone/acetaminophen

oral hydrocodone 10 mg/acetaminophen 650 mg

Intervention Type: DRUG

bupivacaine (supraperiosteal nerve block)

Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root

Intervention Type: DRUG

Other Intervention Names

Lortab; Vicodin; Marcaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Wayne Triner

Professor Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne R Triner, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Albany Medical Center Hospital

Albany, New York, United States

Countries

United States

Other Identifiers

2200

Identifier Type: -

Identifier Source: secondary_id

2200

Identifier Type: -

Identifier Source: org_study_id