Clinical trial NCT02447289: Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment
Official title: Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Child Behavior
Dental Caries
Keywords: Dental caries
Moderate sedation
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-05-18
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Child's behavior measured by an observational scale
timeFrame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
Secondary outcomes:
measure: Acceptance of sedative administration measured by an observational scale
timeFrame: Participants will be assessed for the duration of the sedative administration, an expected average of 3 minutes
measure: Participants' stress according to salivary cortisol
timeFrame: Change from baseline in the salivary cortisol at an expected average of 40 minutes
measure: Pain measured by the FLACC Pain Assessment Tool
timeFrame: Participants will be followed in video files for the duration of the dental session, an expected average of 40 minutes
measure: Caregivers' and dentists' perceptions on sedation measured by a Visual Analogue Scale
timeFrame: During and soon after the dental session
measure: Child's perceptions on sedation through a semi-structured interview
timeFrame: One week after the dental session
measure: Memory of the dental procedure at the immediate post-operative period measured by a validated test
timeFrame: 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
measure: Memory of the dental procedure after 24 hours measured by a validated test
timeFrame: 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
measure: Adverse events during the dental procedure
timeFrame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
measure: Post-operative adverse events
timeFrame: 24 hours
measure: Cost analysis
timeFrame: One year and a half
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Dental School
state: Goias
Study officials:
affiliation: Professor
name: Luciane R Costa, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sado-Filho J, Viana KA, Correa-Faria P, Costa LR, Costa PS. Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation. PLoS One. 2019 Mar 11;14(3):e0213074. doi: 10.1371/journal.pone.0213074. eCollection 2019.
citation: Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.