The effectiveness of Buzzy® in reducing pain associated with intramuscular injection in children
randomized clinical trial
Keywords:
Biomedical Technology, Injections, Intramuscular, Pain, Pediatric Nursing, Randomized Controlled TrialAbstract
Objective: To analyze the effectiveness of the Buzzy® device positioned 15 and 30 seconds before the intramuscular injection in reducing pain in children between one and three years old.
Method: Randomized clinical trial conducted in two Pediatric Emergencies in Southern Brazil between May 2023 and March 2024. The sample was randomized into two groups: Experimental (Buzzy® 15 seconds before the procedure) and Control (Buzzy® 30 seconds before the procedure). The outcomes were pain and behavior. Data analysis was performed using frequencies, relative risks, and statistical tests (Pearson's X² and Fisher's Exact), adopting a 95% confidence interval.
Results: The experimental group had mean pain scores of 4.35 ± 1.2, while the control group had 4.52 ± 1.0. The child with moderate pain/severe discomfort cried during the procedure (p = 0.08) and the behavior with the least association with pain was whimpering (p = 0.08).
Conclusion: There was no statistically significant difference between the groups, but there was a similar clinical effect in both groups. The experimental group showed lower pain scores and fewer reports of moderate pain or severe discomfort.
References
1. Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain [Internet]. 2020 [cited 2025 May 12];161(9):1976-82. Available from: https://doi.org/10.1097/j.pain.0000000000001939
2. Faccioli SC, Tacla MTGM, Rossetto EG, Collet N. The management of pediatric pain and the perception of the nursing team in light of the Social Communication Model of Pain. BrJP [Internet]. 2020 [cited 2025 May 12];3(1):37-41. Available from: https://doi.org/10.5935/2595-0118.20200009
3. Jesus MC, Trindade CS, Lopes J, Ramos AL. Intramuscular Administration of Medication in Paediatrics: integrative literature review. RIASE [Internet]. 2020 [cited 2025 May 15];6(1):2038-53. Available from: http://dx.doi.org/10.24902/r.riase.2020.6(1).310.2117-2133
4. Kurt A, Dinç F, Akkoç B. Effect of the Helfer skin tap technique on pain, anxiety, and fear in children undergoing intramuscular injection: an open-label randomized controlled study. Arch Pediatr [Internet]. 2024 [cited 2025 Apr 12];31(2):148-54. Available from: https://doi.org/10.1016/j.arcped.2023.10.008
5. Jin F, Wang X, Qi M, Zhang W, Zhang Y. Effectiveness and safety of Buzzy device in needle-related procedures for children under twelve years of age: A systematic review and meta-analysis. Medicine [Internet]. 2024 [cited 2025 May 16];103(15):e37522. Available from: https://doi.org/10.1097/MD.0000000000037522
6. Buzzy Medical [Internet]. [place unknown]: Buzzy Medical; 2024 [cited 2025 Apr 14]. O que é o Buzzy;[about 3 screens]. Available from: https://buzzy4shots.com.br/pages/o-que-e-o-buzzy
7. Melzack R, Wall PD. Pain mechanisms: a new theory. Science [Internet]. 1965 [cited 2025 Apr 17];150(3699):971-9. Available from: https://doi.org/10.1126/science.150.3699.971
8. Düzkaya DS, Uysal G, Şiktaş Ö, Karakul A, Açikgöz A. Effects of the Helfer skin tap technique and Buzzy® application on the levels of pain and fear experienced by children during vaccination: a randomized controlled trial. J Pediatr Nurs [Internet]. 2024 [cited 2025 Apr 19];79:e278-e284. Available from: https://doi.org/10.1016/j.pedn.2024.10.037
9. Schulz KF, Altman DG, Moher D; The CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med [Internet]. 2010 [cited 2025 Jun 24];8:18. Available from: https://doi.org/10.1186/1741-7015-8-18
10. Leventhal LC, Bianchi RC, de Oliveira SMJV. Clinical trial comparing three types of cryotherapy in non-pregnant women. Rev Esc Enferm USP [Internet]. 2010 [cited 2025 May 18];44(2):337-43. Available from: https://doi.org/10.1590/S0080-62342010000200014
11. Moura JWS, Silva TL, Bitencourt AS, de Moura SST, Silva BSM, dos Santos LM, et al. Buzzy® and Pikluc® in the relief of pediatric pain in intramuscular injection: randomized clinical trial protocol. Cogitare Enferm [Internet]. 2025 [cited 2025 Jun 2];30:e96620en. Available from: https://doi.org/10.1590/ce.v30i0.96620en
12. da Silva FC, Thuler LCS. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr [Internet]. 2008 [cited 2025 Apr 10];84(4):344-9. Available from: https://doi.org/10.1590/S0021-75572008000400010
13. Costa Júnior AL. Análise de comportamentos de crianças expostas à punção venosa para quimioterapia [thesis]. Brasília: Instituto de Psicologia, Universidade de Brasília; 2001. 280 f.
14. Ministério da Saúde (BR). Resolução Nº 466, de 12 de dezembro de 2012. Aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Diário Oficial da União [Internet]. 2013 Jun 13 [cited 2025 Jun 22];150(112 Seção 1):59-62. Available from: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=13/06/2013&jornal=1&pagina=59&totalArquivos=140
15. da Silva BR, Robalo EC, Gabatz RIB, Couto GR, Cruz VD, de Moraes CL. Perfil de crianças atendidas em um serviço de urgência e emergência no sul do Brasil. J Nurs Health [Internet]. 2021 [cited 2025 Apr 10];11(1):e2111118981. Available from: https://doi.org/10.15210/jonah.v11i1.18981
16. Rodrigues JIB, Fernandes SMGC, Marques GFS. Preocupações e necessidades dos pais de crianças hospitalizadas. Saude Soc [Internet]. 2020 [cited 2025 Apr 12];29(2):e190395. Available from: https://doi.org/10.1590/S0104-12902020190395
17. Şahiner NC, Ínal S, Akbay AS. The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children. J Perianesth Nurs [Internet]. 2015 [cited 2025 May 21];30(3):228-35. Available from: https://doi.org/10.1016/j.jopan.2014.05.011
18. Sapçi E, Kocamaz EB, Gungormus Z. Effects of applying external cold and vibration to children during vaccination on pain, fear and anxiety. Complement Ther Med [Internet]. 2021 [cited 2025 May 22];58:102688. Available from: https://doi.org/10.1016/j.ctim.2021.102688
19. Usach I, Martinez R, Festini T, Peris JE. Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv Ther [Internet]. 2019 [cited 2025 May 29];36:2986-96. Available from: https://doi.org/10.1007/s12325-019-01101-6
20. Simpson KH, Hicks FM. Clinical pharmacokinetics of ondansetron. A review. J Pharm Pharmacol [Internet]. 1996 [cited 2025 May 30];48(8):774-81. Available from: https://doi.org/10.1111/j.2042-7158.1996.tb03973.x
21. da Silva LD, Camerini FG. Analisys of intravenous medication administration in sentinel network hospital. Texto Contexto Enferm [Internet]. 2012 [cited 2025 May 30];21(3):633-41. Available from: https://doi.org/10.1590/S0104-07072012000300019
22. Rezende AF, Vitorino AM, Piran CMG, Shibukawa BMC, Oliveira LM, Higarashi IH, et al. Percepção da criança sobre a hospitalização: revisão integrativa. Rev Feridas [Internet]. 2022 [cited 2025 Apr 15];10(54):1959-64. Available from: https://doi.org/10.36489/feridas.2022v10i54p1959-1964
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Jefferson Wildes da Silva Moura, Gabriela Ferreira Silva, Thiago Lopes Silva, Patrícia de Amorim Rodrigues, Taynarianne Ferreira Alves, Luciano Marques dos Santos, Patrícia Kuerten Rocha
This work is licensed under a Creative Commons Attribution 4.0 International License.
Cogitare Enfermagem reserves the right to make normative, orthographic, and grammatical changes to the published article to maintain the cultured standard of the language, while respecting the authors' style.
The published study is the sole responsibility of the author(s), and Cogitare Enfermagem is exclusively responsible for evaluating the manuscript as a scientific publication vehicle. Revista Cogitare Enfermagem is not responsible for any violations of Law No. 9,610/1998, the Brazilian Copyright Law.
Cogitare Enfermagem allows the author to hold the copyright of articles accepted for publication, without restrictions.
The articles published are licensed under the Creative Commons license CC BY 4.0 Creative Commons - Attribution 4.0 International - CC BY 4.0 - The attribution adopted by Cogitare Enfermagem is permitted:
- Share - copy and redistribute the material in any media or format.
- Adapt - remix, transform and build upon the material for any purpose, even commercially.
- Attribution - You must give proper credit, provide a link to the license, and indicate if changes have been made. You may do this in any reasonable way, but not in a way that suggests that the licensor endorses it or approves of its use.
- No additional restrictions - You may not apply legal terms or technological measures that legally restrict others from doing something that the license allows.
