Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

Summary

Parallel clinical trial focusing on procedural pediatric sedation in the dental setting. Children will be randomized to treatment according to a predetermined sequence of interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control Group). Primary outcome is children's behavior during the dental treatment. Secondary outcomes are: children's pain, memory and stress (salivary cortisol and melatonin); perception of the accompanying adult, dentist and child about dental sedation; cost-effectiveness of this type of sedation; psychosocial variables; children's quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Federal de Goias
• Collaborators: Fundação de Amparo à Pesquisa do Estado de Goiás; Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)
• Treatments: Dexmedetomidine; Ketamine

Criteria

Inclusion Criteria:

• Children born to term, whose physical condition is categorized as American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example)

• Children with a low risk of airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx)

• Children without neurological or cognitive alterations and who do not use medications that may compromise cognitive functions

• Children with caries requiring dental restoration

Exclusion Criteria:

• Children with positive behavior in the consultation without sedation

• Children with facial deformity

• Children using corticosteroid