Status:
COMPLETED
Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
Lead Sponsor:
Universidade Federal de Goias
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)
Conditions:
Caries of Infancy
Dental Anxiety
Eligibility:
All Genders
20-83 years
Phase:
PHASE4
Brief 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: ...
Detailed Description
This proposal aims to determine the most effective pharmacological regimen in the treatment of child pain and anxiety during outpatient dental procedures. Advancement in this field is a reflection, on...
Eligibility Criteria
Inclusion
- 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
- Children with positive behavior in the consultation without sedation
- Children with facial deformity
- Children using corticosteroid
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03290625
Start Date
November 9 2017
End Date
March 5 2020
Last Update
June 30 2020
Active Locations (1)
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1
Dental School
Goiânia, Goiás, Brazil, 74605220