Local AnesthesiaNCT05473819
Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection
A study testing Buffered Local Anesthesia and Conventional Unbuffered Local Anesthesia in people with Local Anesthesia, run by Alexandria University at 1 site in Egypt.
Trial summary
This study will test the effectiveness of addition of Sodium Bicarbonate as a buffering agent to the anaesthetic solution on minimizing the pain of injection and increasing the onset time and potency of the anaesthetic solution in children Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Buffered Local Anesthesia and Conventional Unbuffered Local Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2022to 1 Sep 2022
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range from 5 - 7 years.
- Children free of any systemic disease or special health care need (ASA I).
- No previous bad dental experience.
- Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
- Patients whom their lower primary molars bilaterally are indicated for pulpotomy.
- Patients whom their parents will give consent to participate.
- Patients who give multiple reliable responses while using the transcutaneous electric nerve stimulator device.
Who cannot join
- Active sites of pathosis in area of injection that could affect anaesthetic assessment.
- History of allergy to local anaesthesia.
- Root resorption affecting more than one third of the root length.
- Fractured crowns due to trauma.
- Clinical signs and symptoms of pulp degeneration such as swelling or sinus tracts
- Radiographic evidence of periapical or interradicular radiolucency
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- Non restorable crowns.
- Signs of mobility.
- Ankylosed roots.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Inferior Alveolar Nerve Block in Children : a Randomised Controlled Clinical Trial
This study will test the effectiveness of addition of Sodium Bicarbonate as a buffering agent to the anaesthetic solution on minimizing the pain of injection and increasing the onset time and potency of the anaesthetic solution in children
Read the detailed description
27 healthy cooperative children will be enrolled in the study after taking their guardians' informed consent.
The study design will be a split mouth design where each patient will be received buffered anaesthetic solution (8.4% sodium bicarbonate will be added to the anaesthetic solution in ratio 1:19) in one side and conventional anaesthetic solution (4% articaine HCL with 1:1000000 epinephrine) in the other side.
The pain during injection for each patient in both sides will be then compared using objective and subjective methods.
The onset time of the anaesthesia in both sides will also be compared for each patient using Transcutaneous electric nerve stimulator device (TENS)
The results will be collected and mentioned.
- Conditions
- Local Anesthesia
- Being tested
- Buffered Local Anesthesia, Conventional Unbuffered Local Anesthesia
- Keywords
- buffered, sodium bicarbonate, inferior alveolar nerve block, pain, pulpotomy, articaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered Local AnesthesiaDrug
Buffered local anesthesia will be administered after being previously prepared just before the injection time.
Buffering Local Anesthetic Solutions Using 8.4% Sodium Bicarbonate in a 19:1 Ratio: Using the "REMOVE AND REPLACE hand buffering method"
-Under sterile conditions, 0.09 mL of local anesthetic solution will be removed from the cartridge using a 0.5 mL syringe with a 28- gauge, 0.5-inch needle (Kendall Monoject Insulin Syringe [Tyco Healthcare, tyco.com] lot number 027501). Using a separate unused syringe, 0.09 mL of the commercially available 8.4% sodium bicarbonate will be removed from the 50 mL vial and immediately injected into the local anesthetic cartridge. The cartridge will be inverted 5 times to mix the solution, and no precipitation will be present.
Conventional Unbuffered Local AnesthesiaDrug
The control group will receive the unbuffered conventional anaesthetic solution
| Study group | Role | What they receive |
|---|---|---|
| Buffered Anaesthetic solution | Experimental | 8.4% sodium bicarbonate will be added to the 4% articaine HCL with 1:1000000 epinephrine carpule in ratio 19:1 the Articaine to the Sodium bicarbonate Receives: Drug: Buffered Local Anesthesia |
| Conventional Anaesthetic solution | Active comparator | 4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule Receives: Drug: Conventional Unbuffered Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during inferior alveolar nerve block injection
Sound, Eye, Motor (SEM) Scale (Appendix II), will be used as an objective method for pain assessment. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated by the operator using the recorded video tapes. The slightest manifestations of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1 (comfort), 2 (mild discomfort), 3 (moderate discomfort), and 4 (severe discomfort), respectively. SEM score will be calculated by summing the three grades of the parameters
Measured: during local anesthesia administration
Secondary outcomes (1)
the onset time of the Anaesthesia
Current Perception Threshold (CPT) detection using Transcutaneous Electric Nerve Stimulator (TENS) device. CPT baseline value is the lowest intensity at which the patient first report feeling the stimulus. It determines the Sensory Threshold (ST), which corresponds to the lowest current intensity capable of eliciting perception. The electrode will be placed on the proposed measuring site and the device will be turned on. The device will start the delivery of current at the lowest output intensity and then slowly increased until the patient reported feeling the stimulus. Patients will be instructed to state if they feel any sensation, at that time the delivery of electrical current will be terminated and CPT intensity will be recorded. Every 30 seconds after administration of anaesthesia, while set at the baseline CPT intensity recording for each patient, the electrode will be applied to the proposed measuring site on the anesthetized side, to detect the time of onset of anaesthesia.
Measured: after local anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 May 2022
- Primary completion1 Jun 2022
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Crossover
- Model description
- Split Mouth Design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473819
- Sponsor's protocol ID
- 2890
- Status last verified
- Jan 2022
- First submitted
- 1 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results and the outcomes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Inferior Alveolar Nerve Block in Children : a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05473819
- Acronym / sponsor ID
- 2890
- Conditions
- Local Anesthesia
- Keywords
- buffered, sodium bicarbonate, inferior alveolar nerve block, pain, pulpotomy, articaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Jul 2022 (actual)
- 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 test the effectiveness of addition of Sodium Bicarbonate as a buffering agent to the anaesthetic solution on minimizing the pain of injection and increasing the onset time and potency of the anaesthetic solution in children
Detailed description
27 healthy cooperative children will be enrolled in the study after taking their guardians' informed consent.
The study design will be a split mouth design where each patient will be received buffered anaesthetic solution (8.4% sodium bicarbonate will be added to the anaesthetic solution in ratio 1:19) in one side and conventional anaesthetic solution (4% articaine HCL with 1:1000000 epinephrine) in the other side.
The pain during injection for each patient in both sides will be then compared using objective and subjective methods.
The onset time of the anaesthesia in both sides will also be compared for each patient using Transcutaneous electric nerve stimulator device (TENS)
The results will be collected and mentioned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Buffered Anaesthetic solution | Experimental | Drug: Buffered Local Anesthesia8.4% sodium bicarbonate will be added to the 4% articaine HCL with 1:1000000 epinephrine carpule in ratio 19:1 the Articaine to the Sodium bicarbonate |
| Conventional Anaesthetic solution | Active comparator | Drug: Conventional Unbuffered Local Anesthesia4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age range from 5 - 7 years.
- Children free of any systemic disease or special health care need (ASA I).
- No previous bad dental experience.
- Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
- Patients whom their lower primary molars bilaterally are indicated for pulpotomy.
Key exclusion criteria (9 listed)
- Active sites of pathosis in area of injection that could affect anaesthetic assessment.
- History of allergy to local anaesthesia.
- Root resorption affecting more than one third of the root length.
- Fractured crowns due to trauma.
- Clinical signs and symptoms of pulp degeneration such as swelling or sinus tracts
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 |
|---|---|---|
| Buffered Local AnesthesiaBuffered local anesthesia will be administered after being previously prepared just before the injection time. Buffering Local Anesthetic Solutions Using 8.4% Sodium Bicarbonate in a 19:1 Ratio: Using the "REMOVE AND REPLACE hand buffering method" -Under sterile conditions, 0.09 mL of local anesthetic solution will be removed from the cartridge using a 0.5 mL syringe with a 28- gauge, 0.5-inch needle (Kendall Monoject Insulin Syringe [Tyco Healthcare, tyco.com] lot number 027501). Using a separate unused syringe, 0.09 mL of the commercially available 8.4% sodium bicarbonate will be removed from the 50 mL vial and immediately injected into the local anesthetic cartridge. The cartridge will be inverted 5 times to mix the solution, and no precipitation will be present. | Drug | Buffered Anaesthetic solution |
| Conventional Unbuffered Local AnesthesiaThe control group will receive the unbuffered conventional anaesthetic solution | Drug | Conventional Anaesthetic solution |
Primary outcome
Pain during inferior alveolar nerve block injection
Time frame: during local anesthesia administration
Sound, Eye, Motor (SEM) Scale (Appendix II), will be used as an objective method for pain assessment. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated by the operator using the recorded video tapes. The slightest manifestations of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1 (comfort), 2 (mild discomfort), 3 (moderate discomfort), and 4 (severe discomfort), respectively. SEM score will be calculated by summing the three grades of the parameters
1 secondary outcome
the onset time of the Anaesthesia
Time frame: after local anesthesia administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: Undecided. the results and the outcomes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffered Local Anesthesia and Conventional Unbuffered Local Anesthesia in people with Local Anesthesia, run by Alexandria University at 1 site in Egypt.
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 9 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
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?
Pain during inferior alveolar nerve block injection (time frame: during local anesthesia administration). 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 26 Jul 2022.