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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College
ClinicalTrials.gov Identifier:
NCT00574015
First received: December 13, 2007
Last updated: March 21, 2014
Last verified: September 2010

December 13, 2007
March 21, 2014
December 2007
January 2013   (final data collection date for primary outcome measure)
VAS determination of pain at 30 minutes following intervention [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574015 on ClinicalTrials.gov Archive Site
Numeric scale report or pain Number of prescribed analgesic pills taken [ Time Frame: 24-36 hours following intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Toothache
  • Drug: hydrocodone/acetaminophen
    oral hydrocodone 10 mg/acetaminophen 650 mg
    Other Names:
    • Lortab
    • Vicodin
  • Drug: bupivacaine (supraperiosteal nerve block)
    Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
    Other Name: Marcaine
  • Active Comparator: oral
    administration of oral analgesia
    Intervention: Drug: hydrocodone/acetaminophen
  • Experimental: Dental Block
    Administration of supraperiosteal nerve block to effected tooth
    Intervention: Drug: bupivacaine (supraperiosteal nerve block)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00574015
2200, 2200
No
Wayne Triner, Albany Medical College
Albany Medical College
Not Provided
Principal Investigator: Wayne R Triner, DO, MPH Albany Medical College
Albany Medical College
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP