Buzzy® and Pikluc® in the relief of pediatric pain in intramuscular injection: randomized clinical trial protocol

Abstract

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.