Pain
Conditions
Interventions
This is a randomized, controlled, parallel-group clinical trial with a triple-blind design. Participants will be randomly allocated, using a computer-generated randomization sequence (Sealed Envelope
Sponsors
Faculdade de Odontologia de Piracicaba - UNICAMP
Faculdade de Odontologia de Piracicaba - UNICAMP
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 6 to 12 years, of both genders, requiring dental treatment in the maxillary primary molar region, without spontaneous pain; participants must present positive or definitely positive behavior according to the Frankl Scale, corresponding to scores 3 or 4
Exclusion criteria
Exclusion criteria: Participants presenting allergy to local anesthetics or sulfites; presence of any systemic condition contraindicating the dental procedure; history of adverse reactions to previous dental treatments; presence of lesion or trauma at the anesthetic injection site; use of medications within the previous 24 hours that may interfere with pain perception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe pain perception during local anesthesia, assessed immediately after anesthetic infiltration using the Wong-Baker FACES Pain Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe the child’s behavioral response during local anesthesia, assessed using the FLACC Scale (Face, Legs, Activity, Cry, Consolability);It is expected to observe the child’s heart rate, measured using a pulse oximeter before, during, and immediately after the anesthetic procedure;It is expected to observe peripheral oxygen saturation (SpO2), recorded using a pulse oximeter before, during, and immediately after local anesthesia | — |
Countries
BR
Contacts
Public ContactFelipe Farias-da-Silva
Faculdade de Odontologia de Piracicaba - UNICAMP
Outcome results
None listed