PainPhase 4BufferDentNCT01622296

Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients

A Phase 4 study testing Sodium bicarbonate and Lidocaine in people with Pain, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Sodium bicarbonate and Lidocaine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jul 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 9 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Give written, informed consent (both the subject and the legal guardian)
Be 9-12 years of age
Be able to comprehend the visual analog scale (instructions given to ascertain this)
Be able to comprehend the verbal rating scale (instructions given to ascertain this)
In the opinion of the investigator, be a subject who can be expected to comply with the protocol
Present moderate mandibular dental disease bilaterally
Have 4 to 7 natural teeth (with at least one posterior tooth) present in each mandibular quadrant with moderate dental disease on at least one tooth
Be willing to attend the clinic for 3 or more appointments

Who cannot join

Antibiotic premedication requirement
A history of allergy, sensitivity, or any other form of adverse reactions to local anesthetics of the amide type, or epinephrine
A history of specific systemic illness that would preclude administration of a local anesthetic or vasoconstrictor (epinephrine) (e.g. liver , renal, cardiovascular diseases, blood dyscrasias, psychiatric disorders, etc.)
A history of systemic illness that would interfere with healing response (e.g. liver disease, blood dyscrasias, uncontrolled diabetes, etc.)
Current systemic medication that interferes with healing response
Current systemic medication which contraindicates the use of local anesthetics or epinephrine

Show all 12Show fewer

Pregnant or lactating females (contradicts the use of local anesthetic in non-emergency type dental procedures)
Current alcohol or drug abuse
Received an anesthetic, analgesic or sedative within 24 hours prior to the therapy appointments
Acute infections or conditions in the oral cavity requiring immediate treatment
Participation in a clinical study of an investigational drug within the previous 4 weeks
Previous enrollment in the present study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study

The purpose of this study is to determine the effectiveness of buffered local anesthesia injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine with sodium bicarbonate may reduce the pain of injection for both adults and children. In this study, the investigators will compare two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.

Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection compared to the acidic alternative used in most dental offices. This can be demonstrated by comparing two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.

Read the detailed description

Local anesthesia is an essential procedure in the comprehensive treatment of pediatric patients. In the treatment of subjects with dental disease and infection, local anesthesia is commonly required when performing operative procedures. The use of local anesthesia serves two main purposes: (i) enables the patient to remain free of discomfort during the sometimes painful procedure and (ii) permits the practitioner to complete the procedure without fear of hurting the patient which might otherwise impede the practitioner's ability to provide comprehensive care. However, patients are often fearful of local anesthesia because traditional preparations of local anesthesia are acidic and can be painful. Thus, an important advance in the areas of subject management and pain control during operative procedures would be a preparation of local anesthesia that significantly reduced the pain upon injection. A 2010 Cochrane Review found that adjusting the pH of lidocaine with sodium bicarbonate reduced the pain of injection for both adults and children. In this study, we will compare two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.

The study will test a local anesthetic buffering system, the Onset system, an FDA Class 1 compounding device manufactured by Onpharma Inc. It is a simple and portable local anesthesia buffering system that compounds anesthetic solution and 8.4% sodium bicarbonate neutralizing additive solution in a precise manner that brings the anesthetic solution up to human physiologic pH. Commercially available local anesthetics have a low pH to allow for prolonged shelf life, and to keep the anesthetic molecules in solution. The combination of a buffering sodium bicarbonate agent and local anesthetic has been reported to result in pain-free injections for both adults and children. The neutralizing additive solution is a sterile, nonpyrogenic, solution of sodium bicarbonate (NaHCO3) in water. pH is adjusted with carbon dioxide. Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03) and Lidocaine w/ Epinephrine are compatible. Sodium bicarbonate is used in medicine and dentistry as regularly as saline, and pre-dates the FDA. It is commercially available and currently being used by health professionals in the U.S.A.

The local anesthetic used in the study will be 2% lidocaine with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics. It has been widely used in dentistry and medicine and has long-standing proven records of safety.

Conditions: Pain
Being tested: Sodium bicarbonate, Lidocaine
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium bicarbonateDrug
Also called Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03)
8.4% neutralizing solution
LidocaineDrug
Also called 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics
2% lidocaine with 1:100,000 ppm epinephrine

Study groups in NCT01622296
Study group	Role	What they receive
Sodium Bicarbonate with Lidocaine	Active comparator	Not described Receives: Drug: Sodium bicarbonate
Lidocaine with no buffer	Placebo comparator	Not described Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment
Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 ("no pain") to 100 ("pain as bad as it can be").
Measured: immediately after anesthetic injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jul 2013

First posted19 Jun 2012 (estimated)
Study startApr 2012
Primary completionJul 2012
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01622296
Sponsor's protocol ID: 1107214
Acronym: BufferDent
Status last verified: Feb 2014
First submitted: 11 Jun 2012
Last updated: 17 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.
PubMed 9188235
Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.
PubMed 21154371
von Baeyer CL. Children's self-report of pain intensity: what we know, where we are headed. Pain Res Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1155/2009/259759.
PubMed 19262915

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study
ClinicalTrials.gov ID: NCT01622296
Acronym / sponsor ID: BufferDent / 1107214
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2013 (actual)
First posted: 19 Jun 2012 (estimated)
Results: Posted 17 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Sodium Bicarbonate with Lidocaine	Active comparator	Drug: Sodium bicarbonate
Lidocaine with no buffer	Placebo comparator	Drug: Lidocaine

Who may qualify

Ages: 9 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Give written, informed consent (both the subject and the legal guardian)
Be 9-12 years of age
Be able to comprehend the visual analog scale (instructions given to ascertain this)
Be able to comprehend the verbal rating scale (instructions given to ascertain this)
In the opinion of the investigator, be a subject who can be expected to comply with the protocol

Key exclusion criteria (12 listed)

Antibiotic premedication requirement
A history of allergy, sensitivity, or any other form of adverse reactions to local anesthetics of the amide type, or epinephrine
A history of specific systemic illness that would preclude administration of a local anesthetic or vasoconstrictor (epinephrine) (e.g. liver , renal, cardiovascular diseases, blood dyscrasias, psychiatric disorders, etc.)
A history of systemic illness that would interfere with healing response (e.g. liver disease, blood dyscrasias, uncontrolled diabetes, etc.)
Current systemic medication that interferes with healing response

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
Sodium bicarbonateAlso: Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03)8.4% neutralizing solution	Drug	Sodium Bicarbonate with Lidocaine
LidocaineAlso: 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics2% lidocaine with 1:100,000 ppm epinephrine	Drug	Lidocaine with no buffer

Primary outcome

Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment
Time frame: immediately after anesthetic injection
Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 ("no pain") to 100 ("pain as bad as it can be").

Results and safety

Results posted to the registry on 17 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine First, Then Buffered Lidocaine	10	10
Buffered Lidocaine First, Then Lidocaine	10	10

Primary outcome: Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment

Time frame: immediately after anesthetic injection. Mean (Standard Deviation). Unit: units on a scale

Measure	Lidocaine n = 20	Buffered Lidocaine n = 20
Pain on inferior alveolar nerve block	43 (6)	33.1 (5.5)
Pain on long buccal nerve block	7.3 (1.9)	9.8 (3.9)

Lidocaine vs Buffered Lidocaine: p = 0.23, t-test, 2 sided
Lidocaine vs Buffered Lidocaine: p = 0.57, t-test, 2 sided

Population analysed: per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.

Adverse events

Time frame: up to 48 hours after treatment procedures. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Crossover Lidocaine/Buffered Lidocaine	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): The variation of VAS scores was found to be larger than that used in the sample size calculation; thus, the study was underpowered to reach statistical significance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9188235Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.
Background: PubMed 21154371Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.
Background: PubMed 19262915von Baeyer CL. Children's self-report of pain intensity: what we know, where we are headed. Pain Res Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1155/2009/259759.

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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.

Susan Tavana, DDS principal investigator

University of Caifornia, San Francisco

Peter Loomer, DDS, PhD study chair

University of California, San Francisco

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 Sodium bicarbonate and Lidocaine in people with Pain, run by University of California, San Francisco 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 8 inclusion and 12 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 17 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment (time frame: immediately after anesthetic injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01622296, which also lists 3 linked publications.

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 17 Mar 2014.