Compare the Efficacy of Various Pain Alleviating Methods in Reducing Pain in Children During Intraoral Local Anaesthetic Injections

Anesthesia, Local Clinical Trial

Official title:

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections in Children : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564442
• Other study ID #: 581/2022
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: September 2022
• Source: Minia University
• Contact: Bahy Ibrahim Abdelfatah
• Phone: 01021941938
• Email: Bahyelmelegy63[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: February 1, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• 20% benzocaine gel
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.

Device:
• Transcutaneous electric nerve stimuli
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.

Drug:
• Emla gel
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.

Other:
• Ice application
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.

Locations

Country	Name	City	State
Egypt	El Minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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 ]
Primary	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.	After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
Primary	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.	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 ]
Primary	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.	After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4
Primary	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.	Approximately 2-4 minute after injection.
Primary	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".	Approximately 2-4 minute after injection.