Comparing Buzzy(R) and Pikluc(R) for Pain Relief in Pediatric Intramuscular Injections: A Randomized Equivalence Trial

Pain Manag Nurs. 2026 Apr 21:S1524-9042(26)00126-8. doi: 10.1016/j.pmn.2026.03.016. Online ahead of print.

ABSTRACT

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.

PMID:42020278 | DOI:10.1016/j.pmn.2026.03.016