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Effectiveness of the Pikluc® to relieve pain of intramuscular injection in children and adolescents

Effectiveness of the Pikluc® Device for pain relief associated with intramuscular injections in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10kxn5rs
Enrollment
Unknown
Registered
2023-07-03
Start date
2023-08-01
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

Acute Pain

Interventions

This is a randomized, controlled, parallel and open clinical trial, which was carried out in two pediatric emergency units. The intervention was performed using the Pikluc® device, which is a butterfl

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Hospital Infantil Joana de Gusmão
Collaborator

Eligibility

Age
4 Years to 15 Years

Inclusion criteria

Inclusion criteria: Medical indication for intramuscular injection, in the right or left ventro-gluteal region or right or left deltoid region; to have the possibility of body weighing and height measurement; to be aged between 4 and 15 years; both genders

Exclusion criteria

Exclusion criteria: Cognitive deficit; psychiatric disorders; diseases that felt sensitivity to pain; having ingested substances that affect sensitivity to pain; people who underwent invasive procedures on the same day as the intramuscular injection

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Pain relief reported by the child/adolescent and verified through the researcher's perception according to the Faces Pain Scale-Revised is expected when intramuscular injections are performed using the Pikluc® device

Secondary

MeasureTime frame
Expected outcome 2: An improvement in the behavior of the child/adolescent is expected through the four categories of the Observation Scale of Behavior Distress when Pikluc® is used during intramuscular injections.

Countries

Brazil

Contacts

Public ContactPatrícia Rocha

Universidade Federal de Santa Catarina

nfr@contato.ufsc.br+55 (48) 37219480

Outcome results

None listed

Source: REBEC (via WHO ICTRP)