Clinical trial NCT05083975: Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.
Official title: Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anaesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Children aged 5-8 years old.
3. Patients who need maxillary buccal infiltration anesthesia.

Exclusion Criteria:

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

Primary outcomes:
measure: Pain Perception during local anaesthesia injection
timeFrame: Procedure (During and immediately after the administration of local anesthesia)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
state: Manial
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.