ToothachePhase 4NCT00574015
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
A Phase 4 study testing hydrocodone/acetaminophen and bupivacaine (supraperiosteal nerve block) in people with Toothache, run by Albany Medical College at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Toothache
- What is being tested?
- hydrocodone/acetaminophen and bupivacaine (supraperiosteal nerve block)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Involvement of a single tooth
- Percussive tenderness of the crown of the suspect tooth
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Hospital
Albany, New York, 12208
About this study
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
Read the 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
- Being tested
- hydrocodone/acetaminophen, bupivacaine (supraperiosteal nerve block)
- Keywords
- toothache, regional anesthesia, emergency department
- Medical subject headings
- Toothache, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocodone/acetaminophenDrug
Also called Lortab, Vicodin
oral hydrocodone 10 mg/acetaminophen 650 mg
bupivacaine (supraperiosteal nerve block)Drug
Also called Marcaine
Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
| Study group | Role | What they receive |
|---|---|---|
| oral | Active comparator | administration of oral analgesia Receives: Drug: hydrocodone/acetaminophen |
| Dental Block | Experimental | Administration of supraperiosteal nerve block to effected tooth Receives: Drug: bupivacaine (supraperiosteal nerve block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS determination of pain at 30 minutes following intervention
Measured: 30 minutes
Secondary outcomes (1)
Numeric scale report or pain Number of prescribed analgesic pills taken
Measured: 24-36 hours following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Triner, Albany Medical College
- Investigators
- Wayne R Triner, DO, MPH, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574015
- Sponsor's protocol ID
- 2200
- Other IDs
- 2200
- Status last verified
- Sep 2010
- First submitted
- 13 Dec 2007
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
- ClinicalTrials.gov ID
- NCT00574015
- Acronym / sponsor ID
- 2200
- Conditions
- Toothache
- Keywords
- toothache, regional anesthesia, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral | Active comparator | Drug: hydrocodone/acetaminophenadministration of oral analgesia |
| Dental Block | Experimental | Drug: bupivacaine (supraperiosteal nerve block)Administration of supraperiosteal nerve block to effected tooth |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Involvement of a single tooth
- Percussive tenderness of the crown of the suspect tooth
Key exclusion criteria (15 listed)
- Age younger than 18 years
- Women who are breast feeding
- Allergy or intolerance to hydrocodone, bupivacaine or acetaminophen
- Pregnancy
- Involvement of multiple teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocodone/acetaminophenAlso: Lortab, Vicodinoral hydrocodone 10 mg/acetaminophen 650 mg | Drug | oral |
| bupivacaine (supraperiosteal nerve block)Also: MarcaineAdministration of Bupivacaine 0.5% 2 ml adjacent to tooth root | Drug | Dental Block |
Primary outcome
VAS determination of pain at 30 minutes following intervention
Time frame: 30 minutes
1 secondary outcome
Numeric scale report or pain Number of prescribed analgesic pills taken
Time frame: 24-36 hours following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne R Triner, DO, MPH principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydrocodone/acetaminophen and bupivacaine (supraperiosteal nerve block) in people with Toothache, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS determination of pain at 30 minutes following intervention (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.