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CompletedPhase 4

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

NCT03290625 · Universidade Federal de Goias

Closed to entry
Status
Not accepting participants
Phase 4
Phase
12
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Children's behavior according to observational scale

    Measured over From the beginning to the end of the dental treatment, which should last around 30-40 minutes

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

20 Months to 83 Months
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Dental SchoolGoiâniaGoiásBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03290625 on ClinicalTrials.gov →

Last updated in the registry 2020-06-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

All 2 trials from Universidade Federal de Goias →