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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.
Insights
For young children (1-3 years), Pikluc® and Buzzy® devices provide equivalent pain relief during injections. For older children (4-11 years), results were inconsistent across pain assessment methods.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Clinical Trials
Background:
- Intramuscular injections are a common source of pain in children.
- Non-pharmacological, non-invasive methods are sought for pain relief.
- Devices like Buzzy® and Pikluc® aim to reduce injection pain.
Purpose of the Study:
- To compare the efficacy of Buzzy® (15 seconds and 30 seconds) and Pikluc® for pain relief in children during intramuscular injections.
- To assess pain equivalence across three intervention groups in different age strata.
Main Methods:
- A three-arm, randomized equivalence clinical trial involving children aged 1-11 years.
- Pain assessed using observer-reported (Face, Legs, Activity, Cry, Consolability Scale) and self-reported (Faces Pain Scale - Revised) measures.
- Participants stratified into age groups: 1-3 years and 4-11 years.
Main Results:
- In children aged 1-3 years, all device comparisons (Pikluc® vs. Buzzy® 30s, Buzzy® 15s vs. Pikluc®, Buzzy® 15s vs. Buzzy® 30s) showed equivalent pain relief.
- In children aged 4-11 years, self-reported pain did not demonstrate equivalence across any comparison.
- Observer-reported secondary outcomes suggested equivalence between Pikluc® vs. Buzzy® 30s and Buzzy® 15s vs. Buzzy® 30s for older children.
Conclusions:
- Pikluc® and Buzzy® devices offer equivalent pain relief in children aged 1-3 years during intramuscular injections.
- Inconsistencies in pain assessment (observer, parent, self-report) were noted for children aged 4-11 years.
- Pikluc® offers immediate application, while Buzzy® 15s showed similar efficacy to 30s application in younger children.
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.
