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Comparing BuzzyⓇ and PiklucⓇ for Pain Relief in Pediatric Intramuscular Injections: A Randomized Equivalence Trial
Jefferson Wildes da Silva Moura1, Mari Takashima2, Sabrina de Souza3
1Nursing Post-Graduate Program, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil.
Objective:
To compare three devices: BuzzyⓇ 15 seconds (intervention 1), PiklucⓇ (intervention 2) and BuzzyⓇ 30 seconds (control group) for non-pharmacological, non-invasive pain relief in children during intramuscular injections.
Method:
This was a three-arm, non-masked, parallel-group, randomized equivalence clinical trial in children aged 1-11 years (stratified by: 1-3 and 4-11 years) at two Brazilian Pediatric Emergency Units. The primary outcome is pain, measured by observer-reported pain using the Face, Legs, Activity, Cry, Consolability Scale for children aged 1-3 years and by self-reported pain using the Faces Pain Scale - Revised for children aged 4-11 years. The secondary outcome is pain (parent- and observer-reported) and distress. The study is registered in the Brazilian Clinical Trials Registry under the number RBR-57m3wnw.
Results:
Of 170 participants, 54 were allocated intervention 1, 60 intervention 2, 56 control group. For ages 1-3 years, all comparisons were equivalent: PiklucⓇ vs. BuzzyⓇ 30 seconds (mean score difference [MSD] -0.457; 95% CI: -1.191, 0.277), BuzzyⓇ 15 seconds vs. PiklucⓇ (MSD 0.296; 95% CI: -0.438, 1.030), and BuzzyⓇ 15 seconds vs. BuzzyⓇ 30 seconds (MSD -0.161; 95% CI: -0.912, 0.590). For ages 4-11 years, the primary outcome (self-reported pain) did not show equivalence for any comparison, while observer-reported assessments (secondary outcomes) suggested equivalence for PiklucⓇ vs. BuzzyⓇ 30 seconds and for BuzzyⓇ 15 seconds vs. BuzzyⓇ 30 seconds.
Conclusions:
In children aged 1-3 years, equivalent pain relief was shown across all devices during intramuscular injections. For children aged 4-11 years, there were inconsistencies between observer, parent and self-reported assessments.
Clinical Implications:
For children aged 1-3 years, both PiklucⓇ and BuzzyⓇ devices can be used during intramuscular injections, with PiklucⓇ offering immediate application and BuzzyⓇ 15 seconds showing similar effects to 30 seconds application.
