Anesthesia, LocalNCT05564442
Compare the Efficacy of Various Pain Alleviating Methods in Reducing Pain in Children During Intraoral Local Anaesthetic Injections
A study testing 20% benzocaine gel, Transcutaneous electric nerve stimuli and Emla gel in people with Anesthesia, Local, run by Minia University at 1 site in Egypt.
Trial summary
The aim of study is to compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites compared with 20% benzocaine gel in reducing pain in children requiring anesthesia during routine dental procedures. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- 20% benzocaine gel, Transcutaneous electric nerve stimuli and Emla gel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2022to 1 Feb 2023
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class I and Class II relaying on ASA classification
- Children of the age-group 6-10 years were included in this study.
- Children who are never exposed to TENS, EMLA jelly,
- Children who require LA injections and in whom parental consent was obtained.
- Patients requiring LA for dental procedures such as pulpotomy, or extraction procedure.
- Definitely positive on frankel scale.
Who cannot join
- Children with epileptic disorder.
- Children with a history of cardiac and bleeding disorder.
- Immature children who cannot understand the concept of pain.
- Physically and mentally challenged children.
- Subjects allergic to LA drugs or cartridge components
- Patients having behavioral management problems.
- Patients having previous negative dental experience.
Trial locations and contacts
1 site in 1 country.
Mina Kamal Yassa, Phd contact
Egypt1 site, 1 recruiting
- Recruiting
El Minia university
Minya
Bahy Ibarhim Abdelfatah
About this study
Official title: Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections in Children : A Randomized Controlled Trial
The aim of study is to compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites compared with 20% benzocaine gel in reducing pain in children requiring anesthesia during routine dental procedures.
Read the detailed description
The main concern of the pediatric dentist is to achieve the cooperation of the child in the dental clinic during various pediatric procedures. Administering anesthesia to pediatric patients is the most challenging part of the process. The real fear of the child during a pediatric procedure is painful local anesthetic (LA) injections. The mere sight of needle and syringes cause psychological trauma to the child and thus interferes with the behavior management of a child. Reducing the fear of pain during LA injections gains the confidence of the child toward the dentist, thus achieving the cooperation of the child during treatment .
To reduce the pain during administration of the LA injection, several pharmacological and non-pharmacological methods such as use of topical anesthetics, slowing down the rate of infiltration, distracting the children, vibrating the tissue of the injection site during injection, heat and ice application before the injection have been tested. Application of flavored topical anesthetic gel is most commonly practiced in pediatric dentistry .
Various techniques are available to decrease discomfort during LA injections. Transcutaneous electrical nerve stimulation (TENS) works on the principle of gate control theory. Transcutaneous electrical nerve stimulation directly stimulates the nerves by electrical impulses of short duration and small amplitude for pain reduction during LA injections . Transcutaneous electrical nerve stimulation proved to be more comfortable and beneficial in reducing pain and anxiety during LA injections.
Studies have reported that it lowers edema, nerve conduction velocities, cellular metabolism, and local blood flow .
Topical anesthetic agents are commonly used before the administration of LA . 2% lignocaine gel produces surface anesthesia; however, it has a limited capacity of penetrating deep into tissues. A cutaneous topical anesthetic which was first used in dermatology in the 1980s, Another recommended method to eliminate the pain of injection is cooling of the injection site. This technique has been used in sprains, burns, fractures, bruises, insect bites, and sports injuries
eutectic mixture of lignocaine and prilocaine (EMLA) - "a 1:1 mixture of 2.5% prilocaine and 2.5% lidocaine". The first trial to administer EMLA cream in the mucosal surface was first described by Holst and Evers.
- Conditions
- Anesthesia, Local
- Being tested
- 20% benzocaine gel, Transcutaneous electric nerve stimuli, Emla gel, Ice application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% benzocaine gelDrug
compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.
Transcutaneous electric nerve stimuliDevice
compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.
Emla gelDrug
compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.
Ice applicationOther
compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Children received 20% benzocaine gel | Active comparator | Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections Receives: Drug: 20% benzocaine gel |
| Group II: Children received TENS stimuli | Active comparator | Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections Receives: Device: Transcutaneous electric nerve stimuli |
| Group III: Children received EMLA gel. | Active comparator | Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections Receives: Drug: Emla gel |
| Group IV: Children received ice application at injection site | Active comparator | Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections Receives: Other: Ice application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Heart Rate ( beats/min )
Heart Rate will be measured by using digital manometerReading will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Measured: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]
Heart Rate Measurement after Local Anaesthetic Administration( beats/min )
Heart Rate will be measured by using digital manometer .Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Measured: After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
Baseline blood pressure systolic and diastolic ( mm Hg)
The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.
Measured: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]
Blood pressure measurment (systolic and diastolic)after local anesthetic administration ( mm Hg )
The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.
Measured: After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Approximately 2-4 minute after injection.
Wong-Baker Faces Pain Rating Scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Measured: Approximately 2-4 minute after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start5 Jun 2022
- Primary completion10 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Minia 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahy ibrahim abdelfatah ellmelegy, Minia University
- Investigators
- Bahy Ibarhim Abdelfatah, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564442
- Sponsor's protocol ID
- 581/2022
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections in Children : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05564442
- Acronym / sponsor ID
- 581/2022
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 3 Oct 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.
The aim of study is to compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites compared with 20% benzocaine gel in reducing pain in children requiring anesthesia during routine dental procedures.
Detailed description
The main concern of the pediatric dentist is to achieve the cooperation of the child in the dental clinic during various pediatric procedures. Administering anesthesia to pediatric patients is the most challenging part of the process. The real fear of the child during a pediatric procedure is painful local anesthetic (LA) injections. The mere sight of needle and syringes cause psychological trauma to the child and thus interferes with the behavior management of a child. Reducing the fear of pain during LA injections gains the confidence of the child toward the dentist, thus achieving the cooperation of the child during treatment .
To reduce the pain during administration of the LA injection, several pharmacological and non-pharmacological methods such as use of topical anesthetics, slowing down the rate of infiltration, distracting the children, vibrating the tissue of the injection site during injection, heat and ice application before the injection have been tested. Application of flavored topical anesthetic gel is most commonly practiced in pediatric dentistry .
Various techniques are available to decrease discomfort during LA injections. Transcutaneous electrical nerve stimulation (TENS) works on the principle of gate control theory. Transcutaneous electrical nerve stimulation directly stimulates the nerves by electrical impulses of short duration and small amplitude for pain reduction during LA injections . Transcutaneous electrical nerve stimulation proved to be more comfortable and beneficial in reducing pain and anxiety during LA injections.
Studies have reported that it lowers edema, nerve conduction velocities, cellular metabolism, and local blood flow .
Topical anesthetic agents are commonly used before the administration of LA . 2% lignocaine gel produces surface anesthesia; however, it has a limited capacity of penetrating deep into tissues. A cutaneous topical anesthetic which was first used in dermatology in the 1980s, Another recommended method to eliminate the pain of injection is cooling of the injection site. This technique has been used in sprains, burns, fractures, bruises, insect bites, and sports injuries
eutectic mixture of lignocaine and prilocaine (EMLA) - "a 1:1 mixture of 2.5% prilocaine and 2.5% lidocaine". The first trial to administer EMLA cream in the mucosal surface was first described by Holst and Evers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Children received 20% benzocaine gel | Active comparator | Drug: 20% benzocaine gelComparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections |
| Group II: Children received TENS stimuli | Active comparator | Device: Transcutaneous electric nerve stimuliComparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections |
| Group III: Children received EMLA gel. | Active comparator | Drug: Emla gelComparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections |
| Group IV: Children received ice application at injection site | Active comparator | Other: Ice applicationComparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Class I and Class II relaying on ASA classification
- Children of the age-group 6-10 years were included in this study.
- Children who are never exposed to TENS, EMLA jelly,
- Children who require LA injections and in whom parental consent was obtained.
- Patients requiring LA for dental procedures such as pulpotomy, or extraction procedure.
Key exclusion criteria (7 listed)
- Children with epileptic disorder.
- Children with a history of cardiac and bleeding disorder.
- Immature children who cannot understand the concept of pain.
- Physically and mentally challenged children.
- Subjects allergic to LA drugs or cartridge components
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 |
|---|---|---|
| 20% benzocaine gelcompare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures. | Drug | Group I: Children received 20% benzocaine gel |
| Transcutaneous electric nerve stimulicompare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures. | Device | Group II: Children received TENS stimuli |
| Emla gelcompare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures. | Drug | Group III: Children received EMLA gel. |
| Ice applicationcompare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures. | Other | Group IV: Children received ice application at injection site |
Primary outcome
Baseline Heart Rate ( beats/min )
Time frame: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]
Heart Rate will be measured by using digital manometerReading will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Heart Rate Measurement after Local Anaesthetic Administration( beats/min )
Time frame: After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
Heart Rate will be measured by using digital manometer .Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Baseline blood pressure systolic and diastolic ( mm Hg)
Time frame: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]
The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.
Blood pressure measurment (systolic and diastolic)after local anesthetic administration ( mm Hg )
Time frame: After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
Time frame: Approximately 2-4 minute after injection.
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Wong-Baker Faces Pain Rating Scale
Time frame: Approximately 2-4 minute after injection.
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Mina Kamal Yassa, Phd contact
Bahy Ibarhim Abdelfatah principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20% benzocaine gel, Transcutaneous electric nerve stimuli and Emla gel in people with Anesthesia, Local, run by Minia 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 6 inclusion and 7 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 4 Oct 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?
Contact Bahy Ibrahim Abdelfatah (01021941938, Bahyelmelegy63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Heart Rate ( beats/min ) (time frame: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]). The study lists 6 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 4 Oct 2022.