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Sevoflurane Associated With Oral Midazolam and Ketamine for Dental Sedation

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ClinicalTrials.gov Identifier: NCT02284204
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hugo Sergio de Oliveira Gomes, Universidade Federal de Goias

Brief 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.


Condition or disease Intervention/treatment Phase
Dental Anxiety Drug: Midazolam, Ketamine and Sevoflurane Drug: Midazolam and Ketamine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Other Names:
  • Midazolam, Dormire ® (Cristalia Lab, Sao Paulo, Brazil)
  • Ketamine, Ketamin ® (Cristalia Lab, Sao Paulo, Brazil)

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.
Other Names:
  • Midazolam, Dormire ® (Cristalia Lab, Sao Paulo, Brazil)
  • Ketamine, Ketamin ® (Cristalia Lab, Sao Paulo, Brazil)
  • Sevoflurane, Sevocris ® (Cristalia Lab, Sao Paulo, Brazil)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Brazil
Faculty of Dentistry
Goiania, Goias, Brazil
Sponsors and Collaborators
Universidade Federal de Goias
Investigators
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Principal Investigator: Paulo S Costa, PhD Universidade Federal de Goias

Additional Information:
Publications:
American Academy of Pediatric Dentistry (AAPD). Guideline on Behavior Guidance for the Pediatric Dental Patient. Reference Manual 2013-2014, 35(6): 175-187.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hugo Sergio de Oliveira Gomes, Health Sciences Graduate Program, Federal University of Goias (UFG), Goiania, Goias, Brazil, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT02284204     History of Changes
Other Study ID Numbers: MKSevadversos
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The research data can be shared with other researchers at a reasonable request.

Additional relevant MeSH terms:
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Ketamine
Midazolam
Sevoflurane
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation