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

Phase 4

Completed

• Conditions: Toothache
• Interventions: Drug: hydrocodone/acetaminophen; Drug: bupivacaine (supraperiosteal nerve block)

• Registration Number: NCT00574015
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Status Verified: 2010-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral	hydrocodone/acetaminophen	administration of oral analgesia
Dental Block	bupivacaine (supraperiosteal nerve block)	Administration of supraperiosteal nerve block to effected tooth

Primary Outcome Measures

Name	Time	Method
VAS determination of pain at 30 minutes following intervention	30 minutes

Secondary Outcome Measures

Name	Time	Method
Numeric scale report or pain Number of prescribed analgesic pills taken	24-36 hours following intervention

Trial Locations

Locations (1)

Albany Medical Center Hospital; 🇺🇸 Albany, New York, United States