Anesthesia, LocalPhase 4NCT03562481
Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
A Phase 4 study testing 1% Buffered Lidocaine 1:100,000 Epinephrine and 2% Unbuffered Lidocaine 1:100,000 Epinephrine in people with Anesthesia, Local and Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Pain
- What is being tested?
- 1% Buffered Lidocaine 1:100,000 Epinephrine and 2% Unbuffered Lidocaine 1:100,000 Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 30 Jun 2019
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 10-12 years
- American Society of Anesthesiologists (ASA) Class I (Healthy)
- Body Weight: the Interquartile Range (IQR) 33-60Kg for subject ages
- Have ability to speak and read English
- Willingness to participate in two sessions
- No history of adverse reaction to dental anesthetic
- Have bilateral, disease/symptom-free mandibular first molars present
Who cannot join
- Allergy to lidocaine class of anesthetic drugs
- Local anesthetic drug use in past week
- Current symptomatic teeth or oral mucosa
- ASA II or above (including asthma)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes
Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children.
The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains:
Read more
- Pain experience on injection, time to onset following the administration, and time to recovery [subjective]
- Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia [objective]
Null Hypotheses:
- No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine.
- No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations.
Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate.
One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment.
A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.
- Conditions
- Anesthesia, Local, Pain
- Being tested
- 1% Buffered Lidocaine 1:100,000 Epinephrine, 2% Unbuffered Lidocaine 1:100,000 Epinephrine
- Keywords
- Healthy pediatric volunteers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Buffered Lidocaine 1:100,000 EpinephrineDrug
Also called Xylocaine
A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 EpinephrineDrug
Also called Xylocaine
A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
| Study group | Role | What they receive |
|---|---|---|
| Buffered Anesthetic, then Unbuffered Anesthetic | Experimental | Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. Receives: Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine; Drug: 2% Unbuffered Lidocaine 1:100,000 Epinephrine |
| Unbuffered Anesthetic, then Buffered Anesthetic | Experimental | Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. Receives: Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine; Drug: 2% Unbuffered Lidocaine 1:100,000 Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Scores Following Injection
Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.
Measured: Within 10 minutes of injection
Mean Time to Lower Lip Numbness Following Injection
Time in minutes beginning immediately following injection to patient-reported lip numbness
Measured: Up to 30 minutes following injection
Average Serum Lidocaine Concentration at 15 Minutes Post Injection
Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm).
Measured: One blood draw taken 15 minutes following injection
Mean Time to Baseline Lip Sensation
Response in minutes from injection to when lip is no longer numb, as self reported by patient.
Measured: Within 24 hours following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection
Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection
Measured: 5 minutes prior to injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection
Measured: 30 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection
Measured: 60 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection
Measured: 90 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection
Measured: 120 minutes following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start24 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study subjects will serve as their own controls in this crossover AB/BA study design which is uniform within sequences (groups, i.e. AB/BA, of order of drug formulation administration), uniform within periods (equal time between administration of alternating drug formulations), and balanced (equal number of subjects within each study arm). The randomization will be performed to the type of drug given first, using a balanced randomization (half subjects buffered, half unbuffered) implemented with SAS software routines. During the first session, each subject will receive an IAN block with the first randomly assigned anesthetic formulation using the Halstead technique. At least a week later, substantially longer than the elimination half-life of the drug lidocaine (1.5-2hr), local anesthetic injections will be done using the alternate local anesthetic formulation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Y Lee, DDS,MPH,PhD, Principal investigator, UNC-Chapel Hill School of Dentistry, Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562481
- Sponsor's protocol ID
- 16-3106
- Status last verified
- Feb 2020
- First submitted
- 5 Jun 2018
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03562481
- Acronym / sponsor ID
- 16-3106
- Conditions
- Anesthesia, Local, Pain
- Keywords
- Healthy pediatric volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children.
The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains:
- Pain experience on injection, time to onset following the administration, and time to recovery [subjective]
- Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia [objective]
Null Hypotheses:
- No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine.
- No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations.
Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate.
One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment.
A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study subjects will serve as their own controls in this crossover AB/BA study design which is uniform within sequences (groups, i.e. AB/BA, of order of drug formulation administration), uniform within periods (equal time between administration of alternating drug formulations), and balanced (equal number of subjects within each study arm). The randomization will be performed to the type of drug given first, using a balanced randomization (half subjects buffered, half unbuffered) implemented with SAS software routines. During the first session, each subject will receive an IAN block with the first randomly assigned anesthetic formulation using the Halstead technique. At least a week later, substantially longer than the elimination half-life of the drug lidocaine (1.5-2hr), local anesthetic injections will be done using the alternate local anesthetic formulation.
| Arm | Type | Receives |
|---|---|---|
| Buffered Anesthetic, then Unbuffered Anesthetic | Experimental | Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine, Drug: 2% Unbuffered Lidocaine 1:100,000 EpinephrineSubjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. |
| Unbuffered Anesthetic, then Buffered Anesthetic | Experimental | Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine, Drug: 2% Unbuffered Lidocaine 1:100,000 EpinephrineSubjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 10-12 years
- American Society of Anesthesiologists (ASA) Class I (Healthy)
- Body Weight: the Interquartile Range (IQR) 33-60Kg for subject ages
- Have ability to speak and read English
- Willingness to participate in two sessions
Key exclusion criteria (4 listed)
- Allergy to lidocaine class of anesthetic drugs
- Local anesthetic drug use in past week
- Current symptomatic teeth or oral mucosa
- ASA II or above (including asthma)
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 |
|---|---|---|
| 1% Buffered Lidocaine 1:100,000 EpinephrineAlso: XylocaineA single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique. | Drug | Buffered Anesthetic, then Unbuffered Anesthetic, Unbuffered Anesthetic, then Buffered Anesthetic |
| 2% Unbuffered Lidocaine 1:100,000 EpinephrineAlso: XylocaineA single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique. | Drug | Buffered Anesthetic, then Unbuffered Anesthetic, Unbuffered Anesthetic, then Buffered Anesthetic |
Primary outcome
Mean Pain Scores Following Injection
Time frame: Within 10 minutes of injection
Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.
Mean Time to Lower Lip Numbness Following Injection
Time frame: Up to 30 minutes following injection
Time in minutes beginning immediately following injection to patient-reported lip numbness
Average Serum Lidocaine Concentration at 15 Minutes Post Injection
Time frame: One blood draw taken 15 minutes following injection
Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm).
Mean Time to Baseline Lip Sensation
Time frame: Within 24 hours following injection
Response in minutes from injection to when lip is no longer numb, as self reported by patient.
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection
Time frame: 5 minutes prior to injection
Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection
Time frame: 30 minutes following injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection
Time frame: 60 minutes following injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection
Time frame: 90 minutes following injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection
Time frame: 120 minutes following injection
Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.
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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.
Jessica Y Lee, DDS,MPH,PhD principal investigator
UNC-Chapel Hill School of Dentistry, Pediatric Dentistry
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 1% Buffered Lidocaine 1:100,000 Epinephrine and 2% Unbuffered Lidocaine 1:100,000 Epinephrine in people with Anesthesia, Local and Pain, run by University of North Carolina, Chapel Hill 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 7 inclusion and 4 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 25 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2020). 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?
Mean Pain Scores Following Injection (time frame: Within 10 minutes of injection). The study lists 9 primary outcomes in all. 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 25 Jun 2020.