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Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)

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ClinicalTrials.gov Identifier: NCT02447289
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias

Brief Summary:
Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.

Condition or disease Intervention/treatment Phase
Child Behavior Dental Caries Drug: Intranasal ketamine Drug: Oral ketamine Drug: Intranasal midazolam Drug: Oral midazolam Phase 4

Detailed Description:
About 10% of children may have behavioral problems during dental treatment, but the evidence for sedative protocols that benefit the care in pediatric dentistry are still weak. This randomized, masked, controlled, parallel design study aims to evaluate the efficacy, safety and cost-effectiveness of intranasal sedation with ketamine / midazolam in healthy children aged 2 to 6 years old. Children will be selected among those with dental decay that do not allow dental treatment to be performed, and need at least two restorations under local anesthesia and rubber dam isolation. It is estimated a preliminarily a sample of 84 children equally divided into three groups: A) Ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.2 mg / kg, maximum 5 mg) intranasally; B) ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.5 mg / kg, maximum 20 mg) orally; C) midazolam (1.0 mg / kg, maximum 20 mg) orally. The hypothesis is that ketamine / midazolam combination, administered intranasally, it constitutes an effective sedative regime, safe and cost-effective for use in pediatric dentistry in the public service. The primary endpoint is the behavior of the child. Secondary endpoints are: sedative administration acceptance, procedure memory and salivary cortisol levels within each intervention group. Additionally, we will evaluate: the occurrence of pain and associated changes in facial expressions with potentially painful stimuli in children sedated for dental care; caregivers and paediatric dentists' stress and perception about sedation; adverse events that occur during and after administration of sedatives; cost-effectiveness of the sedative protocols. The experimental design is planned to minimize systematic and random errors and to contribute to higher level of evidence in future systematic reviews. The outcomes of this study have potential impact on public and private health practice, and may support institutional guidelines dealing with this theme.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry: a Randomized Clinical Trial
Actual Study Start Date : May 21, 2015
Actual Primary Completion Date : October 11, 2016
Actual Study Completion Date : October 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Experimental
Intranasal administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.2 mg/kg, max. 5 mg)
Drug: Intranasal ketamine
Ketamine injectable solution in a concentration of 50.0 mg/mL administered into the nose with an atomizer; dose of 4.0 mg/kg, maximum 100.0 mg
Other Name: Ketamin S, Cristalia, São Paulo, Brazil

Drug: Intranasal midazolam
Midazolam injectable solution in a concentration of 5.0 mg/mL administered into the nose with an atomizer; dose of 0.2 mg/kg, maximum 5.0 mg
Other Name: Dormire injectable solution, Cristalia, São Paulo, Brazil

Active Comparator: Comparator
Oral administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.5 mg/kg, max. 20 mg)
Drug: Oral ketamine
Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg
Other Name: Ketamin S, Cristalia, São Paulo, Brazil

Drug: Oral midazolam
Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine; dose of 1.0 mg/kg, maximum 20.0 mg when give as a solely agent
Other Name: Dormire oral solution, Cristalia, São Paulo, Brazil

Active Comparator: Control
Oral administration of midazolam (1.0 mg/kg, max. 20 mg)
Drug: Oral midazolam
Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine; dose of 1.0 mg/kg, maximum 20.0 mg when give as a solely agent
Other Name: Dormire oral solution, Cristalia, São Paulo, Brazil




Primary Outcome Measures :
  1. Child's behavior measured by an observational scale [ Time Frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes ]
    Children's behavior assessed by OSUBRS (Ohio State University Behavioral Rating Scale) in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling. Satisfactory behavior means more than 60% of score 1 during the entire appointment.


Secondary Outcome Measures :
  1. Acceptance of sedative administration measured by an observational scale [ Time Frame: Participants will be assessed for the duration of the sedative administration, an expected average of 3 minutes ]
    Acceptance of the sedative administration, assessed by OSUBRS (Ohio State University Behavioral Rating Scale) minute by minute in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling.

  2. Participants' stress according to salivary cortisol [ Time Frame: Change from baseline in the salivary cortisol at an expected average of 40 minutes ]
    Occurrence of stress during dental procedure, assessed by salivary cortisol in children, their accompanying parent and the dentist in charge; the ELISA test will determine changes in cortisol level during dental treatment

  3. Pain measured by the FLACC Pain Assessment Tool [ Time Frame: Participants will be followed in video files for the duration of the dental session, an expected average of 40 minutes ]
    Occurrence of pain and associated changes in body expressions with potentially painful stimuli in children sedated for dental care

  4. Caregivers' and dentists' perceptions on sedation measured by a Visual Analogue Scale [ Time Frame: During and soon after the dental session ]
    Perception of caregivers and dentists on sedation, through self-report

  5. Child's perceptions on sedation through a semi-structured interview [ Time Frame: One week after the dental session ]
    Child's perception concerning the dental treatment under sedation

  6. Memory of the dental procedure at the immediate post-operative period measured by a validated test [ Time Frame: Participants will be assessed for the recall of the dental procedure, at a time point of 20 minutes (average) after the end of the dental procedure ]
    Memory of the dental procedure, according to test with figures validated in Brazil. Amnesia will be reported if children do not recall the figures showed after sedative administration

  7. Memory of the dental procedure after 24 hours measured by a validated test [ Time Frame: Participants will be assessed for the recall of the dental procedure, at a time point of 24 hours (average) after the end of the dental procedure ]
    Memory of the dental procedure, according to test with figures validated in Brazil. Amnesia will be reported if children do not recall the figures showed after sedative administration

  8. Adverse events during the dental procedure [ Time Frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes ]
    Occurrence of adverse events assessed by the World SIVA tool; adverse events will be categorised into minor, sentinel and major

  9. Post-operative adverse events [ Time Frame: 24 hours ]
    Occurrence of adverse events while child is in the recovery room and after discharge, assessed by the World SIVA tool; adverse events will be categorised into minor, sentinel and major

  10. Cost analysis [ Time Frame: One year and a half ]
    Cost-effectiveness of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease such as persistent asthma)
  • Small risk of airway obstruction (Mallampati less than 2 or tonsillar hypertrophy occupying less than 50% of the oropharynx)
  • No medical history of neurological or cognitive changes
  • Absence of facial deformities
  • Term birth
  • No use of drugs that may impair cognitive functions
  • At least two teeth with cavities without pulp involvement, requiring dental restoration under local anesthesia and rubber dam

Exclusion Criteria:

  • Positive or definitely positive behavior (Frankl et al, 1962) in a dental treatment session conducted by the research team

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): NCT02447289


Locations
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Brazil
Dental School
Goiania, Goias, Brazil, 74605220
Sponsors and Collaborators
Universidade Federal de Goias
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Luciane R Costa, DDS, MS, PhD Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luciane Ribeiro de Rezende Sucasas da Costa, Professor, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT02447289     History of Changes
Other Study ID Numbers: 041530
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD can be available as requested by the scientific journal where the manuscript is gonna be submitted

Keywords provided by Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias:
Dental caries
Moderate sedation

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Ketamine
Midazolam
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