Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.

Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.

The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Local Anesthetics; Epinephrine; Vibration
• Intervention / Treatment: Drug: Topical anesthetic; Drug: Mepivacaine Hydrochloride; Device: Avent baby bottle warmer; Drug: Sodium bicarbonate; Device: Buzzy device

Detailed Description

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data.

Every block will include the equal number of the four groups (three experimental and one control).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sahar H Zidan; Phone Number: 020122217467; Email: szidan750@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children requiring maxillary infiltration LA for dental treatment.
2. Cooperative children (positive or definitely positive on Frankel's scale).
3. Children are in apparently good health and not taking any medications that will alter their pain perception.
4. Children have no history of allergy to Mepivacaine

Exclusion Criteria:

1. The person responsible does not authorize the participation of the child as a research volunteer.
2. Be using pain modulating drugs.
3. Patients with a history of hypersensitivity to local anesthetics.
4. Patients with a history of systemic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control: Traditional local anesthesia; After proper isolation and drying of the injection site, the topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administere	Drug: Topical anesthetic; 20% Benzocaine gel will be applied on the area of infiltration; Drug: Mepivacaine Hydrochloride; Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration
Experimental: Group A (Warm group); The topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds. The cartridge of anesthetic solution will be placed in the baby bottle warmer in 300 ml of cold water (21°C). The anesthetic fluid will be warmed to reach 37°C (98.6°F) ,then the local anesthesia((2% mepivacaine hcl with 1:100000 epinephrine) will be administered	Drug: Topical anesthetic; 20% Benzocaine gel will be applied on the area of infiltration; Drug: Mepivacaine Hydrochloride; Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration; Device: Avent baby bottle warmer; Warming device
Experimental: Group B (Buffered group); The topical anesthetic gel (20% benzocaine) will be applied to the injection site for 60 seconds,0.1ml of 8.4% of sodium bicarbonate will be removed from the 50 ml vial by one ml insulin syringe and directly injected into the local anesthetic cartridge. The cartridge will be shacked 5 times to mix the solution, then the local anesthesia(2% mepivacaine hcl with 1:100000 epinephrine) will be administered.	Drug: Topical anesthetic; 20% Benzocaine gel will be applied on the area of infiltration; Drug: Mepivacaine Hydrochloride; Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration; Drug: Sodium bicarbonate; 0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution.
Experimental: Group C (Buzzy group); After the child setting on the dental chair,(20% benzocaine) topical anesthetic gel will be applied to the injection site for 60 seconds. He will be familiar with the Buzzy device by explaining how it works in simple words. The wings of the device will be kept in the freezer. Once the child is ready, the frozen wings will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic will be delivered. Once Buzzy is being held in place by hand, press the button or switch on the top of Buzzy, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administered.	Drug: Topical anesthetic; 20% Benzocaine gel will be applied on the area of infiltration; Drug: Mepivacaine Hydrochloride; Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration; Device: Buzzy device; Bee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings. External application of Buzzy device during administration of dental anesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Behavoir	The pain will be analyzed by sound ,eye motor scale An assistant will be trained to measure and calibrate the SEM scale. The assistant will be blinded to the study group to avoid bias.	During the anesthetic procedure
Self-perception of pain	The pain will be analyzed by the Wong Baker Faces scales . A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child will be instructed to choose the face that will describe his/ her feelings while receiving local anesthesia	Immediately after anesthesia

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Sahar H Zidan, Dentist at Ministry of Health B.D.S (2013), Diploma (2016); Study Director: Nadia M Farrag, Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University; Study Director: Ahmed H Wahba, Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Publications and helpful links

General Publications

• Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
• Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
• Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6.
• Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 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; Mepivacaine
• Other Study ID Numbers: Dental local anesthesia pain

Drug and device information, study documents

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