CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Midazolam, Ketamine and Sevoflurane +1 moredrug
Likely dose
Not stated in record
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Search/NCT02284204
NCT02284204Phase 2Completed

Use of Sevoflurane, Midazolam and Ketamine in Children for Dental Sedation Treatment: Occurrence of Adverse Events

Universidade Federal de Goias·interventional·Posted Nov 5, 2014·Updated Jan 11, 2017

In Brief

A Phase 2 clinical trial evaluating Midazolam, Ketamine and Sevoflurane and Midazolam and Ketamine for Dental Anxiety. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Anxiety
CountriesBrazil
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2014
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.7 years ago

Interventions

Midazolam, Ketamine and Sevofluranedrug

The combination of these three drugs were administered for the children of the intervention group in a attempt to improve the behavioral control. Midazolam and ketamine orally, sevoflurane inhaled.

Midazolam and Ketaminedrug

The combination of these two drugs were administered orally for the children of the control group.