Buzzy® and Pikluc® in the relief of pediatric pain in intramuscular injection
randomized clinical trial protocol
DOI:
https://doi.org/10.1590/ce.v30i0.96620ptKeywords:
Pediatric Nursing, Injections, Intramuscular, Biomedical Technology, Pain, Clinical Trial ProtocolAbstract
Objective: Describe the protocol for a randomized clinical trial to verify the equivalence of positioning Buzzy® devices for 15 seconds or Pikluc® immediately before administering intramuscular injections for pain relief in children compared to Buzzy® positioned for 30 seconds before the procedure.
Method: Controlled, open-label, equivalence randomized clinical trial protocol with three groups (Buzzy® 15 seconds, Pikluc® and Buzzy® 30 seconds), conducted in two Pediatric Emergency Departments in southern Brazil with children aged 1 to 11 years. The primary outcome is the pain score, while secondary outcomes include pain categorization and assessment of concurrent and non-concurrent behaviors.
Final considerations: The protocol will allow for the evaluation of equivalence between the Buzzy® device applied for 15 seconds before and Pikluc® immediately before intramuscular injection in reducing pain in children, compared to Buzzy® for 30 seconds before the procedure.
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Copyright (c) 2025 Jefferson Wildes da Silva Moura, Thiago Lopes Silva, Aline de Souza Bitencourt, Sayonara Stefane Tavares de Moura, Bianka Sousa Martins Silva, Luciano Marques dos Santos, Patrícia Kuerten Rocha
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