Child Autistic Disorder
Conditions
Interventions
A pilot, parallel, triple-blind, randomized clinical trial will be conducted with 45 children distributed into three parallel groups of children with ASD (6 to 10 years old), classified as definitely
Sponsors
Faculdade de Odontologia da Universidade Federal de Alagoas
Universidade federal de alagoas
Eligibility
Age
6 Years to 10 Years
Inclusion criteria
Inclusion criteria: Age between 6 and 10 years; Both sexes; ASA I classification; Diagnosis of Autism Spectrum Disorder (ASD) requiring support levels 2 or 3; Negative or definitely negative behavior according to the Frankl Behavior Rating Scale (F1 and F2); Inability to undergo dental treatment without sedation due to lack of cooperation; Signed Informed Consent Form (ICF) by parents or legal guardians; Signed Assent Form, when applicable.
Exclusion criteria
Exclusion criteria: Known allergy or hypersensitivity to ketamine or dexmedetomidine; History of cardiac arrhythmia or uncorrected congenital heart disease; Diagnosis of sleep apnea; Concomitant psychiatric disorders; Neurological disorders; ASA II classification or higher; General health condition preventing the performance of study assessments or dental procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of the study will be used to evaluate the efficacy and stability of different Ketodex proportions through behavioral, physiological, and post-procedure recovery parameters; behavior will be assessed using the Houpt et al. (1985) scale, including consciousness (1– fully awake; 2– drowsy/disoriented; 3– asleep), movement (1– violent, interrupting treatment; 2– continuous, making treatment difficult; 3– controllable, without interfering with treatment; 4– no movement), crying (1– hysterical; 2– continuous and persistent, interfering with treatment; 3– intermittent and mild, without interfering with treatment; 4– no crying), and overall behavior at the end of the session (1– aborted, no treatment completed; 2– poor, partially completed treatment; 3– interrupted treatment; 4– difficult, but treatment completed; 5– very good, limited crying or movement; 6– excellent, without crying or movement); physiological outcomes will include peripheral oxygen saturation (SpO2), heart rate (HR), and blood pressure (BP), continuously monitored using a multiparameter monitor, with recordings every minute during anesthesia and every 15 minutes after the procedure; the recovery outcome will be the post-procedure recovery time, defined in minutes from the end of the procedure until the patient reaches a Modified Aldrete Scale score =9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include the occurrence of adverse effects and post-sedation events, observed during and after sedation, such as: prolonged drowsiness, paradoxical effects (agitation and irritability), anterograde amnesia, hallucinations, vomiting, and malaise. | — |
Countries
BR
Contacts
Public ContactLívia Torres
Universidade federal de alagoas
Outcome results
None listed