Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.

NCT05083975 | Completed

• 1 other identifier: Buzzy System in Children.
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.

Conditions

Local Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Perception during local anaesthesia injection

  Pain intensity directly after the injection recorded by Wong-Baker faces pain rating scale and Faces, Legs, Arms, Crying, Consolability (FLACC) scale.

  Procedure (During and immediately after the administration of local anesthesia)

Study Arms (2)

Buzzy System

EXPERIMENTAL

Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds.

Device: Buzzy System; Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Control

ACTIVE COMPARATOR

Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel.

Drug: Topical anesthetic; Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Interventions

Buzzy System DEVICE

Vibrating Device

Buzzy System

Topical anesthetic DRUG

20% benzocaine gel (Opahl Topical Gel)

Control

1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000 DRUG

Local dental anesthetic agent

Buzzy System; Control

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
• Children aged 5-8 years old.
• Patients who need maxillary buccal infiltration anesthesia.

You may not qualify if:

• Children with any neurological or psychological disorders.
• Children with known allergy to topical or local anesthetic agents.
• Parental refusal for participation.
• Children with previous history of local anesthesia injection.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Manial, Egypt

Location

Related Publications (10)

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 BACKGROUND

• Hegde KM, R N, Srinivasan I, D R MK, Melwani A, Radhakrishna S. Effect of vibration during local anesthesia administration on pain, anxiety, and behavior of pediatric patients aged 6-11 years: A crossover split-mouth study. J Dent Anesth Pain Med. 2019 Jun;19(3):143-149. doi: 10.17245/jdapm.2019.19.3.143. Epub 2019 Jun 30.

  PMID: 31338420 BACKGROUND

• Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.

  PMID: 30519955 BACKGROUND

• Suohu T, Sharma S, Marwah N, Mishra P. A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System. Int J Clin Pediatr Dent. 2020 Jan-Feb;13(1):27-30. doi: 10.5005/jp-journals-10005-1731.

  PMID: 32581474 BACKGROUND

• AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.

  PMID: 33564311 BACKGROUND

• Faghihian R, Rastghalam N, Amrollahi N, Tarrahi MJ. Effect of vibration devices on pain associated with dental injections in children: A systematic review and meta-analysis. Aust Dent J. 2021 Mar;66(1):4-12. doi: 10.1111/adj.12811. Epub 2020 Dec 17.

  PMID: 33258142 BACKGROUND

• Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.

  PMID: 32129952 BACKGROUND

• Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.

  PMID: 31842771 BACKGROUND

• Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.

  PMID: 17331753 BACKGROUND

MeSH Terms

Interventions

Anesthetics, Local; Carticaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the patient and the investigator cannot be blinded due to the different techniques.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: July 23, 2022
• Primary Completion: December 22, 2022
• Study Completion: May 6, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)