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Effectiveness of Buzzy® and Pikluc® in relieving pain associated with intramuscular injection in children

Effectiveness of Buzzy® and Pikluc® in relieving pain associated with intramuscular injection in children: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57m3wnw
Enrollment
Unknown
Registered
2024-05-22
Start date
2023-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injections, Intramuscular

Interventions

This is a randomized, controlled, factorial and open clinical study. Experimental Group 1 will consist of 42 children who will wear the Buzzy device positioned for 15 seconds before the intramuscular

Sponsors

Programa de Pós-Graduação em Enfermagem da Universidade Federal de Santa Catarina
Lead Sponsor
Hospital Infantil Joana de Gusmão da Secretaria de Estado da Saúde de Santa Catarina
Collaborator

Eligibility

Age
1 Years to 11 Years

Inclusion criteria

Inclusion criteria: To be in the age range of 1 to 11 years, 11 months, and 29 days old. Have a medical prescription for intramuscular injection

Exclusion criteria

Exclusion criteria: Child with Raynaud's disease or other vasospastic disorders. Hypersensitivity to cold. Cardiac disorders with impairment of local circulation. Rheumatoid disease. Hypertensive disease. Anesthetized skin

Design outcomes

Primary

MeasureTime frame
Assess pain associated with intramuscular injection in children. It is expected to find scores of no pain or mild pain associated with intramuscular injection in children. Verified in children aged 1 to 3 years, 11 months and 29 days by the researcher using the Face, Legs, Activity, Cry, Consolability Scale and in children aged between 4 and 11 years, 11 months and 29 days through self-report, researcher assessment and responsible using the Faces Pain Scale Revised

Secondary

MeasureTime frame
Evaluate behavior associated with intramuscular injection in children. The child is expected to display collaborative behaviors during the intramuscular injection. Verified by the researcher using variables from the Observation Scale of Behavior Distress

Countries

Brazil

Contacts

Public ContactJefferson Moura

Universidade Federal de Santa Catarina

jefferson.wsmoura@gmail.com+55 (81) 995609384

Outcome results

None listed

Source: REBEC (via WHO ICTRP)