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

Toothache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574015
• Other study ID #: 2200
• Secondary ID: 2200
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2007
• Last updated: March 21, 2014
• Start date: December 2007
• Est. completion date: January 2013

Study information

• Verified date: September 2010
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Toothache

Intervention

Drug:
• hydrocodone/acetaminophen
oral hydrocodone 10 mg/acetaminophen 650 mg
• bupivacaine (supraperiosteal nerve block)
Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root

Locations

Country	Name	City	State
United States	Albany Medical Center Hospital	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS determination of pain at 30 minutes following intervention		30 minutes	No
Secondary	Numeric scale report or pain Number of prescribed analgesic pills taken		24-36 hours following intervention	No