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CompletedPhase 2

Sevoflurane Associated With Oral Midazolam and Ketamine for Dental Sedation

NCT02284204 · Universidade Federal de Goias

Closed to entry
Status
Not accepting participants
Phase 2
Phase
27
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

There is still extensive debate on the best method of controlling the behavior of preschool children during dental treatment. Protective stabilization, moderate sedation and general anesthesia are advanced behavior control techniques indicated for the dental treatment of early childhood caries and offer advantages and disadvantages during the procedure or immediately after. Many children with early childhood caries require invasive dental treatment. According to the final report of a large epidemiological survey on the oral condition of Brazilians, five-year-old children had an average of 2.43 primary teeth with caries and fewer than 20% of these had been treated in 2010. This disease also remains a public health problem in most developed countries; 19.5% of 2-5-year-old American children have untreated cavities. There is, however, a lack of the ideal sedative. Such drugs must, on the one hand, control the behavior of integral form, provide amnesia, minimizing physical discomfort, distress and pain, and, on the other, safeguard security, with minimal effect on the cardio-respiratory function, minimizing the occurrence of adverse events, as well as allowing the return of the patient to a State that allows high safely. The investigators thus performed this prospective study with the aim to assess the occurrence of adverse events during dental treatment and in the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children aged four to six years. Our hypothesis was that no differences in adverse events among different association of drugs could be found.

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

  • adverse events

    Measured over in the first 24 hours after sedation for dental treatment

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

4 Years to 6 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Children ASA I or II; * Need for restorative procedure on at least one deciduous tooth below; * Airway patent and effective nasal breathing; * Behavior not collaborator in previous dental treatment. Exclusion Criteria: * Previous experience of dental treatment under sedation; * Have completed seven years during the data collection.

Where

1 study site

FacilityCityRegionCountry
Faculty of DentistryGoiâniaGoiásBrazil

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.

NCT02284204 on ClinicalTrials.gov →

Last updated in the registry 2017-01-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits