Sevoflurane Associated With Oral Midazolam and Ketamine for Dental Sedation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02284204|
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : January 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety||Drug: Midazolam, Ketamine and Sevoflurane Drug: Midazolam and Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Sevoflurane, Midazolam and Ketamine in Children for Dental Sedation Treatment: Occurrence of Adverse Events|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Midazolam and Ketamine
In this arm, the children received, orally, the combination of midazolam and ketamine. Midazolam, at a dose of 0.5 mg/kg (maximum dose 20 mg) and ketamine, at a dose of 3 mg/kg (maximum dose 50 mg). This combination of drugs were administered fifteen minutes before the start of treatment sessions.
Drug: Midazolam and Ketamine
The combination of these two drugs were administered orally for the children of the control group.
Experimental: Midazolam, Ketamine and Sevoflurane
In this arm, the children received, orally, the combination of midazolam and ketamine. Midazolam, at a dose of 0.5 mg/kg (maximum dose 20 mg) and ketamine, at a dose of 3 mg/kg (maximum dose 50 mg). After fifteen minutes of this drug administration, the investigators start to provide sevoflurane, through a nasal hood, in an initial concentration of 0.1%, with 0.1% increment every 30 seconds, until a final expired concentration between 0.3 and 0.4%.
Drug: Midazolam, Ketamine and Sevoflurane
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.
- adverse events [ Time Frame: in the first 24 hours after sedation for dental treatment ]Evaluate the occurrence of adverse events during restorative dental treatment and in the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children four to six years.
- Behavioral Control [ Time Frame: Houpt scores were established every minute of the dental treatment (estimated in 60 minutes), and in three specific moments (at the local anesthesia, at the use of high rotation and at the end of treatment), in addition to an overall evaluation ]Evaluate the behavioral control of children undergoing sedation with midazolam, ketamine and sevoflurane during dental treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284204
|Faculty of Dentistry|
|Goiania, Goias, Brazil|
|Principal Investigator:||Paulo S Costa, PhD||Universidade Federal de Goias|