Pediatric DentistryNCT01883232
The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient
A study testing Onset Mixing Pen by Onpharma and 2% lidocaine with 1:100,000 epinephrine in people with Pediatric Dentistry, run by University of Colorado, Denver at 1 site in United States.
Trial summary
As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dentistry
- What is being tested?
- Onset Mixing Pen by Onpharma and 2% lidocaine with 1:100,000 epinephrine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2016
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Current patients of Children's Hospital Colorado Dental Clinic
- Existence of carious primary molars necessitating administration of an anesthetic agent
- No history of post traumatic stress disorder or specific phobia related to a dental setting
- No allergic reaction to lidocaine
- Patient's between the ages of 5 to 12.
Who cannot join
- Allergies to local anesthetics or sulfites
- History of significant medical conditions
- Taking any medications that may affect anesthetic assessment
- Active sites of pathology in areas if injection
- Outside the age range of 5 -12.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado Dental Clinic
Aurora, Colorado, 80045
About this study
As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Of the many reasons for pain at the site of injection, the acidity of the solution is thought to be most important. This study will be measuring the effects of adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in medical applications but is not widely used in the dental setting. Using this biochemistry and human physiology, one can predict when buffering the lidocaine injection, a quicker response in analgesia and a decrease in pain during administration. I will be measuring the effect using several measuring devices to gauge if buffering the local anesthetic will benefit the pediatric dental patient by reducing the time it takes for the analgesic effect as well as decreasing the pain during administration. Along with time, I will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in the pediatric population. The pediatric dental population has aversions to dental procedures because of the associated pain produced from most procedures. If limiting the time it takes for the analgesic to take effect and decrease the pain altogether, the pediatric patient will be less likely to skip treatment therefore, increase dental health.
- Conditions
- Pediatric Dentistry
- Being tested
- Onset Mixing Pen by Onpharma, 2% lidocaine with 1:100,000 epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onset Mixing Pen by OnpharmaDevice
Sodium Bicarbonate 8.4%
2% lidocaine with 1:100,000 epinephrineDevice
2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| 2% lidocaine with 1:100,000 epinephrine | Active comparator | 2% lidocaine with 1:100,000 epinephrine Receives: Device: 2% lidocaine with 1:100,000 epinephrine |
| Onset Mixing Pen by Onpharma | Experimental | Sodium Bicarbonate 8.4% mixed with the onset mixing pen Receives: Device: Onset Mixing Pen by Onpharma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain rating using the Wong-Baker scale
By buffering the lidocaine/epinephrine injection, one should see a decrease in in pain during the administration of the anesthetic.
Measured: During injection (about 5 minutes)
Time it takes for buffered injection to take effect measured in minutes.
minutes for the analgesic effect to take place.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pediatric DentistryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Esker, DMD, Principal investigator, Children's Hospital Colorado Dental Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883232
- Sponsor's protocol ID
- 13-0298
- Status last verified
- Dec 2015
- First submitted
- 17 May 2013
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kashyap VM, Desai R, Reddy PB, Menon S. Effect of alkalinisation of lignocaine for intraoral nerve block on pain during injection, and speed of onset of anaesthesia. Br J Oral Maxillofac Surg. 2011 Dec;49(8):e72-5. doi: 10.1016/j.bjoms.2011.04.068. Epub 2011 May 18.
PubMed 21592633Grassick P. The fear behind the fear: a case study of apparent simple injection phobia. J Behav Ther Exp Psychiatry. 1990 Dec;21(4):281-7. doi: 10.1016/0005-7916(90)90030-o.
PubMed 1982735Arndt KA, Burton C, Noe JM. Minimizing the pain of local anesthesia. Plast Reconstr Surg. 1983 Nov;72(5):676-9. doi: 10.1097/00006534-198311000-00017.
PubMed 6622575Meit SS, Yasek V, Shannon CK, Hickman D, Williams D. Techniques for reducing anesthetic injection pain: an interdisciplinary survey of knowledge and application. J Am Dent Assoc. 2004 Sep;135(9):1243-50. doi: 10.14219/jada.archive.2004.0399.
PubMed 15493388Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.
PubMed 16384767Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.
PubMed 23050753Malamed SF, Falkel M. Advances in local anesthetics: pH buffering and dissolved CO2. Dent Today. 2012 May;31(5):88-93; quiz 94-5. No abstract available.
PubMed 22650087Christoph RA, Buchanan L, Begalla K, Schwartz S. Pain reduction in local anesthetic administration through pH buffering. Ann Emerg Med. 1988 Feb;17(2):117-20. doi: 10.1016/s0196-0644(88)80293-2.
PubMed 2827545Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.
PubMed 18784857
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient
- ClinicalTrials.gov ID
- NCT01883232
- Acronym / sponsor ID
- 13-0298
- Conditions
- Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 21 Jun 2013 (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.
As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Of the many reasons for pain at the site of injection, the acidity of the solution is thought to be most important. This study will be measuring the effects of adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in medical applications but is not widely used in the dental setting. Using this biochemistry and human physiology, one can predict when buffering the lidocaine injection, a quicker response in analgesia and a decrease in pain during administration. I will be measuring the effect using several measuring devices to gauge if buffering the local anesthetic will benefit the pediatric dental patient by reducing the time it takes for the analgesic effect as well as decreasing the pain during administration. Along with time, I will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in the pediatric population. The pediatric dental population has aversions to dental procedures because of the associated pain produced from most procedures. If limiting the time it takes for the analgesic to take effect and decrease the pain altogether, the pediatric patient will be less likely to skip treatment therefore, increase dental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% lidocaine with 1:100,000 epinephrine | Active comparator | Device: 2% lidocaine with 1:100,000 epinephrine2% lidocaine with 1:100,000 epinephrine |
| Onset Mixing Pen by Onpharma | Experimental | Device: Onset Mixing Pen by OnpharmaSodium Bicarbonate 8.4% mixed with the onset mixing pen |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Current patients of Children's Hospital Colorado Dental Clinic
- Existence of carious primary molars necessitating administration of an anesthetic agent
- No history of post traumatic stress disorder or specific phobia related to a dental setting
- No allergic reaction to lidocaine
- Patient's between the ages of 5 to 12.
Key exclusion criteria (5 listed)
- Allergies to local anesthetics or sulfites
- History of significant medical conditions
- Taking any medications that may affect anesthetic assessment
- Active sites of pathology in areas if injection
- Outside the age range of 5 -12.
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 |
|---|---|---|
| Onset Mixing Pen by OnpharmaSodium Bicarbonate 8.4% | Device | Onset Mixing Pen by Onpharma |
| 2% lidocaine with 1:100,000 epinephrine2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure | Device | 2% lidocaine with 1:100,000 epinephrine |
Primary outcome
Change in pain rating using the Wong-Baker scale
Time frame: During injection (about 5 minutes)
By buffering the lidocaine/epinephrine injection, one should see a decrease in in pain during the administration of the anesthetic.
Time it takes for buffered injection to take effect measured in minutes.
Time frame: 5 minutes
minutes for the analgesic effect to take place.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Results publication: PubMed 21592633Kashyap VM, Desai R, Reddy PB, Menon S. Effect of alkalinisation of lignocaine for intraoral nerve block on pain during injection, and speed of onset of anaesthesia. Br J Oral Maxillofac Surg. 2011 Dec;49(8):e72-5. doi: 10.1016/j.bjoms.2011.04.068. Epub 2011 May 18.
- Results publication: PubMed 1982735Grassick P. The fear behind the fear: a case study of apparent simple injection phobia. J Behav Ther Exp Psychiatry. 1990 Dec;21(4):281-7. doi: 10.1016/0005-7916(90)90030-o.
- Results publication: PubMed 6622575Arndt KA, Burton C, Noe JM. Minimizing the pain of local anesthesia. Plast Reconstr Surg. 1983 Nov;72(5):676-9. doi: 10.1097/00006534-198311000-00017.
- Results publication: PubMed 15493388Meit SS, Yasek V, Shannon CK, Hickman D, Williams D. Techniques for reducing anesthetic injection pain: an interdisciplinary survey of knowledge and application. J Am Dent Assoc. 2004 Sep;135(9):1243-50. doi: 10.14219/jada.archive.2004.0399.
- Results publication: PubMed 16384767Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.
- Results publication: PubMed 23050753Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.
- Results publication: PubMed 22650087Malamed SF, Falkel M. Advances in local anesthetics: pH buffering and dissolved CO2. Dent Today. 2012 May;31(5):88-93; quiz 94-5. No abstract available.
- Results publication: PubMed 2827545Christoph RA, Buchanan L, Begalla K, Schwartz S. Pain reduction in local anesthetic administration through pH buffering. Ann Emerg Med. 1988 Feb;17(2):117-20. doi: 10.1016/s0196-0644(88)80293-2.
- Results publication: PubMed 18784857Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.
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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.
Valerie Esker, DMD principal investigator
Children's Hospital Colorado Dental Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onset Mixing Pen by Onpharma and 2% lidocaine with 1:100,000 epinephrine in people with Pediatric Dentistry, run by University of Colorado, Denver 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Dec 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in pain rating using the Wong-Baker scale (time frame: During injection (about 5 minutes)). The study lists 2 primary outcomes in all. 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 NCT01883232, which also lists 9 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 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.