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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

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date April 30, 2018
Actual Study Start Date  ICMJE May 21, 2015
Actual Primary Completion Date October 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • 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 ]
    Improvement in child's behavior evaluated minute by minute, according to the Houpt scale, where scores 2 or 3 (sleep), 3 or 4 (cry and movement), and 4, 5 and 6 for overall behavior will represent good behavior
  • 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 Houpt scale. Scores 3 or 4 for cry and movement will represent a good acceptance.
  • 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
  • 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
  • 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
  • Cost analysis [ Time Frame: One year ]
    Cost-effectiveness of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Pain measured by the Child Facial Coding System [ Time Frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes ]
    Occurrence of pain and associated changes in facial expressions with potentially painful stimuli in children sedated for dental care
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment
Official Title  ICMJE Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry: a Randomized Clinical Trial
Brief Summary Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Child Behavior
  • Dental Caries
Intervention  ICMJE
  • 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: 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: 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
  • 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
Study Arms  ICMJE
  • Experimental: Experimental
    Intranasal administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.2 mg/kg, max. 5 mg)
    Interventions:
    • Drug: Intranasal ketamine
    • Drug: Intranasal midazolam
  • Active Comparator: Comparator
    Oral administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.5 mg/kg, max. 20 mg)
    Interventions:
    • Drug: Oral ketamine
    • Drug: Oral midazolam
  • Active Comparator: Control
    Oral administration of midazolam (1.0 mg/kg, max. 20 mg)
    Intervention: Drug: Oral midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2015)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 18, 2016
Actual Primary Completion Date October 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02447289
Other Study ID Numbers  ICMJE 041530
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: IPD can be available as requested by the scientific journal where the manuscript is gonna be submitted
Responsible Party Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Study Sponsor  ICMJE Universidade Federal de Goias
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Principal Investigator: Luciane R Costa, DDS, MS, PhD Professor
PRS Account Universidade Federal de Goias
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP