Acute pain
Conditions
Interventions
This is a randomized, parallel clinical study involving 32 healthy children aged 8 to 12 years, of both sexes. Participants will be recruited from the pediatric dentistry clinic of the Federal Univers
Sponsors
Universidade Federal do Piauí
Universidade Federal do Piauí
Eligibility
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: Healthy children; of both sexes; aged between 8 and 12 years; who require dental procedures with infiltration anesthesia in the posterior region of the maxilla; treated at the pediatric dentistry outpatient clinic of the Federal University of Piauí
Exclusion criteria
Exclusion criteria: Patients who are feeling pain at the time of the clinical examination; with a history of allergy to benzocaine or oxybuprocaine; who have used analgesics or anti-inflammatories up to 24 hours before the procedure; with syndromes or behavioral changes; those whose parents/guardians do not authorize participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome to be measured will be the average self-reported pain at the time of anesthetic puncture measured by the Visual Analog Scale (VAS). The VAS scale is a psychometric scale applied for subjective assessment of pain. The scale presents variations in colors and facial expressions along a 10 cm line, whose starting point (zero) means “no pain” and the end point (ten) means “severe pain”. To measure pain, the child selects a point on the scale that quantifies the pain he/she felt after application of the stimulus (anesthetic puncture). The classifications range from 0 (no pain), 1 to 2 (mild pain), 3 to 7 (moderate pain), 8 to 10 (severe pain). After the anesthetic puncture, the child will indicate on the scale the level of pain perceived on the VAS scale. The average of the responses obtained will be calculated to measure this outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be the average disruptive pain at the time of anesthetic puncture measured by the Brazilian version of the FLACC scale (Face, Legs, Activity, Cry, Consolability Scale). The FLACC scale allows the recording of disruptive pain from the researcher's perspective. At the time of stimulation, facial expressions, motor activity of the legs, as well as the emission of sounds, crying, activity and consolation of the child after the procedure will be observed and recorded. The scale consists of five categories: face, legs, activity, crying and consolability. Each category can score from 0 to 2. The pain score is obtained by the simple sum of the points obtained in each of the categories evaluated during the anesthetic puncture. The classification of reactions can be classified as absence of pain (score = 0), mild pain (score = 1-3), moderate pain (score = 4-6) and severe pain (score = 7-10). After the anesthetic puncture is complete, a researcher blinded to the type of topical anesthesia will assess the patient's pain response by filming the anesthetic procedure. The average of the scores obtained will be calculated to measure this outcome | — |
Countries
Brazil
Contacts
Public ContactMarina Lima
Universidade Federal do Piauí
Outcome results
None listed