Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)

June 26, 2020 updated by: Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias

Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II): Randomized Clinical Trial

Parallel clinical trial focusing on procedural pediatric sedation in the dental setting. Children will be randomized to treatment according to a predetermined sequence of interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control Group). Primary outcome is children's behavior during the dental treatment. Secondary outcomes are: children's pain, memory and stress (salivary cortisol and melatonin); perception of the accompanying adult, dentist and child about dental sedation; cost-effectiveness of this type of sedation; psychosocial variables; children's quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This proposal aims to determine the most effective pharmacological regimen in the treatment of child pain and anxiety during outpatient dental procedures. Advancement in this field is a reflection, on the one hand, of the use of new and more effective routes of drug administration, such as the intranasal route using atomizers with uniform dispersion of the administered jet and, on the other hand, the use of new sedative drugs, such as dexmedetomidine. This is a randomized, parallel, triple-masked clinical trial, using a research protocol with the objectives: 1) To evaluate the efficacy (behavior, pain, memory and stress) of a sedative regimen intranasally mucosal atomizer device (MAD) using a sedative drug (ketamine) and an innovative drug (dexmedetomidine) in the sedation of children from 2 to 6 years of age undergoing dental treatment - our hypothesis is that the use of dexmedetomidine intranasally association with ketamine is more effective than dexmedetomidine itself in isolation; 2) To analyze the level of cortisol and salivary melatonin (stress) according to each sedative protocol and its association with clinical variables; 3) Identify adverse events with the new protocol; 4) To evaluate the association between the child's behavior and psychosocial variables; 5) To verify the impact of treatment under dental sedation on the quality of life related to the oral health of the child. The research will be carried out in the Faculty of Dentistry of the Federal University of Goias, in the Center of Studies in Dental Sedation (NESO), Goiânia, Goias. A non-probabilistic sample of 88 children aged 2 to 6 years (alpha 0.05, 80% power) who present dental caries with restorative need, American Society of Anesthesiologists I or II, patent nasal airways (Mallampati index I or II and obstruction by hypertrophy of tonsils ≤ 50% and effective nasal breathing), in addition to non-cooperative behavior with the examination or a dental procedure. Children with neuropathies, those using growth hormone and / or those who exhibit severe adverse events during sedation will be excluded. Children will be randomized to treatment according to a predetermined sequence of interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control Group). Pediatricians and anesthesiologists will be aware of the randomized intervention, because of safety concerns for the child, in the case of serious adverse events with or without immediate use of antagonists; the other staff members and the child's companion (s) will be "masked". The examination and intervention sessions will be filmed in high definition for later analysis of the behavior and pain according to different scales consecrated and / or validated. In addition, the children will be submitted to four saliva collections to analyze the levels of cortisol and melatonin (stress-related hormones). Other variables of secondary outcome are: perception of the accompanying adult, dentist and child about dental sedation and cost-effectiveness of this type of sedation, psychosocial variables, quality of life. The data will be analyzed by descriptive and bivariate statistics. This proposal will bring benefits in the vast field of health sedation by having original design, using drugs and promising routes, with national and international impact. The project is inserted in a research line that presents experience history and impact publications by the proponent team, as well as involving students of scientific initiation, master's, doctorate, and postdoctoral studies, being developed by a multidisciplinary team. There is a clear expectation of generating results with high impact production, besides the possibility of immediate application in the public and private sectors of a highly effective sedative regime, minimizing the need to refer patients to general anesthesia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Goiania, Goias, Brazil, 74605220
        • Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children born to term, whose physical condition is categorized as American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example)
  • Children with a low risk of airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx)
  • Children without neurological or cognitive alterations and who do not use medications that may compromise cognitive functions
  • Children with caries requiring dental restoration

Exclusion Criteria:

  • Children with positive behavior in the consultation without sedation
  • Children with facial deformity
  • Children using corticosteroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DexKet
Intranasal DEXMEDETOMIDINE (2.0 mcg/kg, maximum 100 mcg) + KETAMINE (1.0 mg/kg, maximum 100 mg)
Drug: Dexmedetomidine Hydrochloride
Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection
Drug: Ketamine Hydrochloride
Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection
Active Comparator: Dex
DEXMEDETOMIDINE (2.5 mcg/kg, maximum 100 mcg)
Drug: Dexmedetomidine Hydrochloride
Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's behavior according to observational scale
Time Frame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
Children's behavior during the dental treatment under sedation according to the observational scale 'Ohio State University Behavioral Rating Scale' (OSUBRS) as assessed by trained and calibrated observers in the video files of the procedure
From the beginning to the end of the dental treatment, which should last around 30-40 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptance of intranasal administration according to observation
Time Frame: From the beginning to the end of the intranasal sedative administration, which should less than one minute each
Acceptance of intranasal sedative regimen administration using a pre-defined form; trained and calibrated observers will assess children's acceptance through symptoms such as crying, need for physical restraint, and others
From the beginning to the end of the intranasal sedative administration, which should less than one minute each
Memory of the procedure through questionnaire
Time Frame: From the children's arrival at the dental clinic until discharge, and then on the day after, up to 36 hours
Children's memory of facts that happened just before and after the administration of the sedative, through a questionnaire exploring toys showed and procedures occurred just before and during the procedure
From the children's arrival at the dental clinic until discharge, and then on the day after, up to 36 hours
Salivary cortisol according to ELISA
Time Frame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
Children's salivary cortisol related to the dental treatment under sedation assessed through ELISA
From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
Salivary melatonin according to ELISA
Time Frame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
Children's salivary melatonin related to the dental treatment under sedation assessed through ELISA
From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
Pain according to the FLACC scale
Time Frame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
Children's pain during the dental treatment under sedation, assessed by trained and calibrated observers using the Faces, Legas, Activity, Consolability and Crying scale (FLACC) in digital video files related to the procedure
From the beginning to the end of the dental treatment, which should last around 30-40 minutes
Accompanying person perception through VAS
Time Frame: Just after the end of the child's dental procedure, while in the recovery anesthetic room, an average of 60 minutes
Accompanying person perception on the child's sedation through Visual Analogue Scale
Just after the end of the child's dental procedure, while in the recovery anesthetic room, an average of 60 minutes
Pediatric dentist perception through VAS
Time Frame: Just after the end of the child's dental procedure, an average of 60 minutes
Pediatric dentist perception on the child's sedation through Visual Analogue Scale
Just after the end of the child's dental procedure, an average of 60 minutes
Child's perception through qualitative interview
Time Frame: One week after the dental sedation procedure
Child's perception on the dental procedure under sedation, according to a qualitative interview following a semistructured guide
One week after the dental sedation procedure
Adverse events
Time Frame: During the procedure and within the 24 hours after
Post-operative adverse events related to the dental sedation procedure
During the procedure and within the 24 hours after
Child's dental anxiety and sedation efficacy, according to the Venham's picture test
Time Frame: Fifteen minutes before the administration of the sedative
Association of child's dental anxiety with the outcome of the procedural sedation, using the Venham Picture Test
Fifteen minutes before the administration of the sedative
Child's dental behavior in the reception and sedation efficacy, according to the Sharath Scale
Time Frame: Fifteen minutes before the administration of the sedative
Association of child's dental behavior with the outcome of the procedural sedation, using the Sharath scale
Fifteen minutes before the administration of the sedative
Parents' anxiety and sedation efficacy, according to the STAI
Time Frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Association of parental overall anxiety with the outcome of the procedural sedation, using short form of the State-Trate Anxiety Inventory (STAI)
On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Parents' dental anxiety and sedation efficacy, according to the Corah Scale
Time Frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Association of parental dental anxiety with the outcome of the procedural sedation, using Dental Anxiety Scale by Corah
On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Parents' overall stress and sedation efficacy, according to the Lipp Inventory
Time Frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Association of parental stress with the outcome of the procedural sedation, using the according to the "Inventário de Sintomas de Stress para Adultos de Lipp - ISSL" (Lipp Adult Stress Symptoms Inventory - ISSL)
On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
Procedural dental sedation impact according to the B-ECOHIS
Time Frame: Two weeks and three months after the completion of the dental treatment
Impact of dental treatment under sedation on the oral health related quality of life related to the child and respective family, using the questionnaire B-ECOHIS
Two weeks and three months after the completion of the dental treatment
Economic analysis
Time Frame: After the completion of data collection for the primary outcome, an average of 4 years
Cost-effectiveness analysis of the two sedative regimens
After the completion of data collection for the primary outcome, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Goias

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciane Costa, PhD, Universidade Federal de Goias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PV0939-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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