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OpenTrials
Completed

NCT Number: NCT00574015

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albany Medical Center Hospital

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrocodone/Acetaminophen

Drug

oral hydrocodone 10 mg/acetaminophen 650 mg

Other names: Lortab, Vicodin

bupivacaine (supraperiosteal nerve block)

Drug

Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root

Other names: Marcaine

Primary outcomes

  1. VAS determination of pain at 30 minutes following intervention

    Time frame: 30 minutes

Secondary outcomes

  1. Numeric scale report or pain Number of prescribed analgesic pills taken

    Time frame: 24-36 hours following intervention

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 14, 2007
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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