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

NCT ID: NCT05564442

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2023-02-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Group I: Children received 20% benzocaine gel

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Group Type: ACTIVE_COMPARATOR

20% benzocaine gel

Intervention Type: DRUG

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.

Group II: Children received TENS stimuli

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Group Type: ACTIVE_COMPARATOR

Transcutaneous electric nerve stimuli

Intervention Type: DEVICE

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.

Group III: Children received EMLA gel.

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Group Type: ACTIVE_COMPARATOR

Emla gel

Intervention Type: DRUG

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.

Group IV: Children received ice application at injection site

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Group Type: ACTIVE_COMPARATOR

Ice application

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Bahy ibrahim abdelfatah ellmelegy

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bahy Ibarhim Abdelfatah

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

El Minia university

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Bahy Ibrahim Abdelfatah

Role: CONTACT

Bahyelmelegy63@gmail.com

01021941938

Mina Kamal Yassa, Phd

Role: CONTACT

0 111 5332387

Facility Contacts

Bahy Ibarhim Abdelfatah

Role: primary

Other Identifiers

581/2022

Identifier Type: -

Identifier Source: org_study_id