Child
Conditions
Interventions
This is a two-arm, triple-blind, randomized controlled clinical study. Group experimental: 40 children in need of treatment for primary molars (restoration and extraction), who received local anesthes
E03.155.086.231
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
7 Years to 10 Years
Inclusion criteria
Inclusion criteria: Children between 7 and 10 years old are eligible; no systemic compromise; ASA I and II; both sexes; previous experience or not with dental anesthesia; need for dental treatment such as extractions, restorations and endodontic treatment in deciduous lower molars
Exclusion criteria
Exclusion criteria: Patients with acute pain; presence of odontogenic infection; emergency cases; history of bleeding or blood clotting problems; history of allergy to the drugs used in the research; history of asthma; liver disease; neurological disorders; use of analgesic or anti-inflammatory medication up to 5 hours before the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome assessed will be the report of pain during anesthetic injection, with the anesthetic solution heated to body temperature (37 °C) compared to anesthetic injection with a solution at room temperature (21 °C), both using 2% lidocaine 1: 100,000 with epinephrine, by measuring pain at the time of anesthetic injection. The instrument used to measure pain will be the Face, Legs, Activity, Cry, Consolability (FLACC) scale applied by a calibrated evaluator blinded to the anesthetic temperature. The application of the FLACC scale is done by observation, without the need for the child to respond, the patterns of face, legs, activity, crying and comfortability are evaluated, assigning scores from 0 to 3 for each item, with 0 = no pain and 3 = a lot of pain. This instrument will be applied during the infiltrative anesthesia procedure for lower primary molars. | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's anxiety: Assessed using the FIS scale comprises 5 drawings of faces that vary from very happy to very unhappy. The child will receive the following explanation: “These pictures show how you feel, “very happy” – and the operator will point to the very happy face – to “very unhappy” – and the operator will point to the very unhappy face”. The child will then be asked to point to the face that most resembles them at that moment with the question: “Which figure do you look like at that moment?” value 1 will be assigned to the most positive face up to value 5 for the more negative face.;Determine clinical time: Clinical time will be measured with the aid of a digital stopwatch from the application of the topical anesthetic to the end of the anesthetic injection. Total operative time will be recorded in minutes.;Child behavior: The scale used will be Frankl's, which will be applied by a calibrated, trained and blinded evaluator to the anesthetic tube used. This scale separates behaviors into four graded categories: definitely negative, negative, positive, and definitely positive. This scale will be used to evaluate behavior during care;Anxiety of those responsible: The dental anxiety of those responsible will be assessed in the dental office, shortly before seeing your child, using the Dental Anxiety Scale (DAS). This instrument consists of four questions that assess how the respondent feels about dental treatment and will be applied in the office shortly before the procedure for those responsible. Each question has five answer options and the total score varies from 0 to 20. The degree of anxiety will be interpreted as follows: 15 points = extreme anxiety. In the office, prior to treatment, the questionnaire was delivered and filled out by those responsible. For statistical analysis, the variable will be dichotomized, considering very low and mild anxiety as low and moderate and extreme anxiety as high;Self-reported pain or discomfort during anesthesia: The Wo | — |
Countries
Brazil
Contacts
Public ContactKarina Cardoso
Universidade Federal de Santa Catarina
Outcome results
None listed