Acute Pain
Conditions
Interventions
This is a four-arm, open-label, superiority randomized controlled clinical trial with a 1:1:1:1 allocation ratio. The total number of participants will be 120 children divided into two subgroups: 12 t
s vaccination will be the use of Buzzy Mini® devices, placed for 30 seconds before the procedure on the right vastus lateralis of the thigh, subsequently slid 3 cm, switched on, diagonally towards the
Sponsors
Universidade Estadual de Feira de Santana
Universidade Estadual de Feira de Santana
Eligibility
Age
12 Months to 48 Months
Inclusion criteria
Inclusion criteria: Age 12 to 48 months and 29 days; both sexes; child awake; child accompanied by parents or legal guardian over 18 years old capable of consenting; not having received analgesics or sedatives in the 12 hours before entry into the research; indication for meningitis vaccine via intramuscular route at the time of inclusion; breastfeeding children and mother available to breastfeed before and during the procedure
Exclusion criteria
Exclusion criteria: Fever equal to or greater than 37.5°C on the day; cold hypersensitivity; Raynaud's disease; sickle cell anemia; vascular diseases; having undergone needle interventions on the same day; skin lesions or nodules at the application site; cognitive deficit or any psychiatric condition such as autism, depression or anxiety; severe neurological conditions that alter behavioral assessment such as epilepsy or cerebral palsy; history of severe adverse reactions to vaccines; withdrawal by the guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate acute pain intensity in children during the administration of the ACWY meningococcal vaccine; using as an instrument for pain measurement the translated and adapted FLACC (Face, Legs, Activity, Cry, Consolability) behavioral scale; behaviors will be observed and the scale filled out, wherein the sum score of the five domains will result in a final pain score ranging from 0 to 10 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the child's behavioral response, clinical characteristics and the viability of the pilot study; using time measurement and data monitoring for indicator calculation; cry duration time and consolation time in seconds, gestational age at birth, occurrence of previous hospitalization and percentages regarding eligibility, recruitment, retention, protocol fidelity, missing data and data loss rates will be observed | — |
Countries
Brazil
Contacts
Public ContactValesca Correia
Universidade Estadual de Feira de Santana
Outcome results
None listed