Child, Exceptional
Conditions
Interventions
This is a two-arm, open-label, randomized controlled clinical trial. A total of 50 children with intellectual disabilities who meet the eligibility criteria will be randomly allocated into one of the
Sponsors
Universidade Federal do Rio de Janeiro
Faculdade de Odontologia da Universidade Federal do Rio de Janeiro
Eligibility
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children of both genders; with a physical status classification from I to III, as defined by the American Society of Anesthesiologists; aged between 3 and 12 years; prior diagnosis of intellectual disability confirmed by caregivers; behavior classified as negative or definitely negative on the Frankl scale during screening at the Clinic for Children with Disabilities of the Department of Pediatric Dentistry at the Faculty of Dentistry of the Federal University of Rio de Janeiro, indicating the need for protective stabilization to perform dental treatment; need for dental treatment identified during screening, including restoration, pulpal therapy, or simple extraction
Exclusion criteria
Exclusion criteria: Children weighing less than 15 kg; airway classification by the modified Mallampati scale equal to or greater than III; medical contraindication for intranasal medication sedation, inhalation sedation, or protective stabilization; presence of disabilities without intellectual impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find differences in stress and anxiety levels among children, caregivers, and the operating pediatric dentist when comparing conscious sedation with intranasal midazolam associated with nitrous oxide inhalation to protective stabilization. The assessment will be conducted through questionnaires applied to caregivers and the pediatric dentist before and after the dental procedure, as well as salivary cortisol analysis collected from patients and operators at pre- and post-treatment moments. Caregivers and the pediatric dentist will respond to the State-Trait Anxiety Inventory to evaluate anxiety as a trait and as a state, and caregivers will also answer the Dental Anxiety Scale questionnaire, which consists of four questions assessing the level of anxiety related to dental treatment, with a score ranging from 0 to 20 points, where less than 5 indicates low anxiety, 6 to 10 mild anxiety, 11 to 15 moderate anxiety, and above 15 extreme anxiety. Cortisol measurement will be performed before and after the procedure through saliva collection using Salivette tubes, where a cotton roll will be kept in the mouth for 60 seconds until saturation, with safety ensured by tying dental floss around the cotton roll. The samples will be collected 10 minutes before medication administration or the start of the procedure and 25 minutes after completion, being stored at -20°C until analysis. On the day of analysis, samples will be thawed and centrifuged at 3000 rpm for 15 minutes and evaluated in duplicate using the Enzyme-Linked Immunosorbent Assay method;It is expected to find differences in clinical parameters and the incidence of adverse effects among children undergoing conscious sedation with intranasal midazolam associated with nitrous oxide inhalation compared to those undergoing protective stabilization. The assessment will be conducted through clinical monitoring before, during, and after the dental procedure, including sedation level measurement using the R | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactGloria Castro
Universidade Federal do Rio de Janeiro
Outcome results
None listed