Local AnesthesiaNCT06519838
Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children
A study testing Local anesthesia solution at room temperature, Local anesthesia solution pre-warmed to 37°C and Local anesthesia solution pre-warmed to 40°C in people with Local Anesthesia and Dental Anesthesia, run by Andrew Emad at 1 site in Egypt.
Trial summary
The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Local Anesthesia, Dental Anesthesia
- What is being tested?
- Local anesthesia solution at room temperature, Local anesthesia solution pre-warmed to 37°C and Local anesthesia solution pre-warmed to 40°C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 10 Jun 2024
- 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
- No healthy volunteers
- Child
Who may be able to join
- Healthy patients with ASA 1 or 2 Classification.
- Patients with Frankl Behavior Classification 3-4.
- Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
- Parents' willingness to participate through informed written consent.
Who cannot join
- Patients with previous negative dental experience.
- Patients complaining of cellulitis or infection spreading in the fascial spaces.
- Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
- Patients with any Intellectual Impairment.
- Patients with a history of allergy from any of the components of the dental anesthetic carpule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children: A Randomized Controlled Clinical Trial
The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children
- Conditions
- Local Anesthesia, Dental Anesthesia
- Being tested
- Local anesthesia solution at room temperature, Local anesthesia solution pre-warmed to 37°C, Local anesthesia solution pre-warmed to 40°C, Maxillary infiltration technique, Inferior alveolar nerve block technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia solution at room temperatureOther
The local anesthesia cartridge is used at room temperature (average of 21 °C)
Local anesthesia solution pre-warmed to 37°COther
About 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 37°C at 120 seconds.
Local anesthesia solution pre-warmed to 40°COther
About 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 40°C at 130 seconds.
Maxillary infiltration techniqueOther
A 30 gauge short needle is oriented so that the bevel is facing the bone. The syringe is held parallel to the long axis of the tooth and the needle is inserted into the height of the mucobuccal fold over the offending tooth. The needle is advanced to a depth of 1 millimeter into the tissues. Aspiration is done, and once it is negative then 0.6 ml (nearly one third of the cartridge) of the anesthetic solution is injected slowly without permitting the tissues to balloon.
Inferior alveolar nerve block techniqueOther
While the mouth is opened as wide as possible, the index finger palpates the external oblique ridge reaching the Coronoid notch. A 27-gauge long dental needle will be used for injection. The needle will be directed between the two primary molars on the opposing side of the arch, penetrating the tissues at the point halfway between coronoid notch and the pterygomandibular raphe at the occlusal plane level or slightly lower.The needle is withdrawn 2mm to aspirate. Once negative aspiration is checked, the remainder of the solution is deposited slowly. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. The average depth of insertion is about 15mm, which is nearly two-thirds the needle length.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary infiltration at room temperature | Active comparator | Not described Receives: Other: Local anesthesia solution at room temperature; Other: Maxillary infiltration technique |
| Inferior alveolar nerve block at room temperature | Active comparator | Not described Receives: Other: Local anesthesia solution at room temperature; Other: Inferior alveolar nerve block technique |
| Maxillary infiltration pre-warmed to 37°C | Experimental | Not described Receives: Other: Local anesthesia solution pre-warmed to 37°C; Other: Maxillary infiltration technique |
| Inferior alveolar nerve block pre-warmed to 37°C | Experimental | Not described Receives: Other: Local anesthesia solution pre-warmed to 37°C; Other: Inferior alveolar nerve block technique |
| Maxillary infiltration pre-warmed to 40°C | Experimental | Not described Receives: Other: Local anesthesia solution pre-warmed to 40°C; Other: Maxillary infiltration technique |
| Inferior alveolar nerve block pre-warmed to 40°C | Experimental | Not described Receives: Other: Local anesthesia solution pre-warmed to 40°C; Other: Inferior alveolar nerve block technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR) monitoring
A pulse oximeter will be used to record and measure the patient's heart rate. A baseline reading will be obtained before the LA administration and another reading will be obtained directly after the injection is carried out. Heart rate ranging between 70-100 is considered normal.
Measured: during local anesthesia administration
Pain during injection using Sound, Eye, Motor (SEM) Scale
Sound, Eye, Motor (SEM) Scale was used as an objective mean to assess pain during local anesthesia administration. It comprises the following parameters:
- Sound
- Eye
- Bodily movements The slightest changes in the sound, eye movement and bodily movement of the patient will be categorized as one of the following levels; comfortable, mild, moderate, and severe discomfort and hence given a grade of 1, 2, 3 or 4 respectively. The final SEM score will be calculated by adding the grades of the three parameters.
Measured: during local anesthesia administration
Pain during injection using Face scale
To assess pain subjectively during local anesthesia administration, a modified face scale. It consists of three schematic faces with different facial expressions for happy and sad faces representing:
- Satisfaction
- Indifference
- Dissatisfaction Each patient was trained on using the scale by modelling and then requesting from every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one
Measured: during 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 posted25 Jul 2024
- Study start1 Jan 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
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.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Emad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Emad, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519838
- Sponsor's protocol ID
- 1/2023
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06519838
- Acronym / sponsor ID
- 1/2023
- Conditions
- Local Anesthesia, Dental Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Andrew EmadUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 25 Jul 2024 (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.
The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Maxillary infiltration at room temperature | Active comparator | Other: Local anesthesia solution at room temperature, Other: Maxillary infiltration technique |
| Inferior alveolar nerve block at room temperature | Active comparator | Other: Local anesthesia solution at room temperature, Other: Inferior alveolar nerve block technique |
| Maxillary infiltration pre-warmed to 37°C | Experimental | Other: Local anesthesia solution pre-warmed to 37°C, Other: Maxillary infiltration technique |
| Inferior alveolar nerve block pre-warmed to 37°C | Experimental | Other: Local anesthesia solution pre-warmed to 37°C, Other: Inferior alveolar nerve block technique |
| Maxillary infiltration pre-warmed to 40°C | Experimental | Other: Local anesthesia solution pre-warmed to 40°C, Other: Maxillary infiltration technique |
| Inferior alveolar nerve block pre-warmed to 40°C | Experimental | Other: Local anesthesia solution pre-warmed to 40°C, Other: Inferior alveolar nerve block technique |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy patients with ASA 1 or 2 Classification.
- Patients with Frankl Behavior Classification 3-4.
- Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
- Parents' willingness to participate through informed written consent.
Key exclusion criteria (5 listed)
- Patients with previous negative dental experience.
- Patients complaining of cellulitis or infection spreading in the fascial spaces.
- Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
- Patients with any Intellectual Impairment.
- Patients with a history of allergy from any of the components of the dental anesthetic carpule.
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 |
|---|---|---|
| Local anesthesia solution at room temperatureThe local anesthesia cartridge is used at room temperature (average of 21 °C) | Other | Inferior alveolar nerve block at room temperature, Maxillary infiltration at room temperature |
| Local anesthesia solution pre-warmed to 37°CAbout 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 37°C at 120 seconds. | Other | Inferior alveolar nerve block pre-warmed to 37°C, Maxillary infiltration pre-warmed to 37°C |
| Local anesthesia solution pre-warmed to 40°CAbout 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 40°C at 130 seconds. | Other | Inferior alveolar nerve block pre-warmed to 40°C, Maxillary infiltration pre-warmed to 40°C |
| Maxillary infiltration techniqueA 30 gauge short needle is oriented so that the bevel is facing the bone. The syringe is held parallel to the long axis of the tooth and the needle is inserted into the height of the mucobuccal fold over the offending tooth. The needle is advanced to a depth of 1 millimeter into the tissues. Aspiration is done, and once it is negative then 0.6 ml (nearly one third of the cartridge) of the anesthetic solution is injected slowly without permitting the tissues to balloon. | Other | Maxillary infiltration at room temperature, Maxillary infiltration pre-warmed to 37°C, Maxillary infiltration pre-warmed to 40°C |
| Inferior alveolar nerve block techniqueWhile the mouth is opened as wide as possible, the index finger palpates the external oblique ridge reaching the Coronoid notch. A 27-gauge long dental needle will be used for injection. The needle will be directed between the two primary molars on the opposing side of the arch, penetrating the tissues at the point halfway between coronoid notch and the pterygomandibular raphe at the occlusal plane level or slightly lower.The needle is withdrawn 2mm to aspirate. Once negative aspiration is checked, the remainder of the solution is deposited slowly. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. The average depth of insertion is about 15mm, which is nearly two-thirds the needle length. | Other | Inferior alveolar nerve block at room temperature, Inferior alveolar nerve block pre-warmed to 37°C, Inferior alveolar nerve block pre-warmed to 40°C |
Primary outcome
Heart rate (HR) monitoring
Time frame: during local anesthesia administration
A pulse oximeter will be used to record and measure the patient's heart rate. A baseline reading will be obtained before the LA administration and another reading will be obtained directly after the injection is carried out. Heart rate ranging between 70-100 is considered normal.
Pain during injection using Sound, Eye, Motor (SEM) Scale
Time frame: during local anesthesia administration
Sound, Eye, Motor (SEM) Scale was used as an objective mean to assess pain during local anesthesia administration. It comprises the following parameters: * Sound * Eye * Bodily movements The slightest changes in the sound, eye movement and bodily movement of the patient will be categorized as one of the following levels; comfortable, mild, moderate, and severe discomfort and hence given a grade of 1, 2, 3 or 4 respectively. The final SEM score will be calculated by adding the grades of the three parameters.
Pain during injection using Face scale
Time frame: during local anesthesia administration
To assess pain subjectively during local anesthesia administration, a modified face scale. It consists of three schematic faces with different facial expressions for happy and sad faces representing: 1. Satisfaction 2. Indifference 3. Dissatisfaction Each patient was trained on using the scale by modelling and then requesting from every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one
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 25 Jul 2024.
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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 Local anesthesia solution at room temperature, Local anesthesia solution pre-warmed to 37°C and Local anesthesia solution pre-warmed to 40°C in people with Local Anesthesia and Dental Anesthesia, run by Andrew Emad 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 4 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: finished, as of the sponsor's last update on 25 Jul 2024. 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?
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?
Heart rate (HR) monitoring (time frame: during local anesthesia administration). The study lists 3 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 Jul 2024.