Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
Status:
Completed
Trial end date:
2020-03-05
Target enrollment:
Participant gender:
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
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)