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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: 20% benzocaine gel; Device: Transcutaneous electric nerve stimuli; Drug: Emla gel; Other: Ice application

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 Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahy Ibrahim Abdelfatah; Phone Number: 01021941938; Email: Bahyelmelegy63@gmail.com
• Study Contact Backup: Name: Mina Kamal Yassa, Phd; Phone Number: 0 111 5332387

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • El Minia university
    • Contact: Bahy Ibarhim Abdelfatah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: Children received 20% benzocaine gel; Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections	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.
Active Comparator: Group II: Children received TENS stimuli; Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections	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.
Active Comparator: Group III: Children received EMLA gel.; Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections	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.
Active Comparator: Group IV: Children received ice application at injection site; Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ]
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
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 ]
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
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.
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.

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Bahy Ibarhim Abdelfatah, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: 581/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No