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

NCT02447289 | Completed Phase 4

• 1 other identifier: 041530
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child Behavior; Dental Caries

Keywords

Dental caries; Moderate sedation

Outcome Measures

Primary Outcomes (1)

• Child's behavior measured by an observational scale

  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.

  Participants will be followed for the duration of the dental session, an expected average of 40 minutes

Secondary Outcomes (10)

• Acceptance of sedative administration measured by an observational scale

  Participants will be assessed for the duration of the sedative administration, an expected average of 3 minutes

• Participants' stress according to salivary cortisol

  Change from baseline in the salivary cortisol at an expected average of 40 minutes

• Pain measured by the FLACC Pain Assessment Tool

  Participants will be followed in video files for the duration of the dental session, an expected average of 40 minutes

• Caregivers' and dentists' perceptions on sedation measured by a Visual Analogue Scale

  During and soon after the dental session

• Child's perceptions on sedation through a semi-structured interview

  One week after the dental session

Study Arms (3)

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; Drug: Intranasal midazolam

Comparator

ACTIVE COMPARATOR

Oral administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.5 mg/kg, max. 20 mg)

Drug: Oral ketamine; Drug: Oral midazolam

Control

ACTIVE COMPARATOR

Oral administration of midazolam (1.0 mg/kg, max. 20 mg)

Drug: Oral midazolam

Interventions

Intranasal ketamine DRUG

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

Also known as: Ketamin S, Cristalia, São Paulo, Brazil

Experimental

Oral ketamine DRUG

Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg

Also known as: Ketamin S, Cristalia, São Paulo, Brazil

Comparator

Intranasal midazolam DRUG

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

Also known as: Dormire injectable solution, Cristalia, São Paulo, Brazil

Experimental

Oral midazolam DRUG

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

Also known as: Dormire oral solution, Cristalia, São Paulo, Brazil

Comparator; Control

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Dental School

Goiânia, Goiás, 74605220, Brazil

Location

Related Publications (2)

• 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.

  PMID: 30856181 DERIVED

• 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.

  PMID: 28399933 DERIVED

MeSH Terms

Conditions

Child Behavior; Dental Caries

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavior; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luciane R Costa, DDS, MS, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 18, 2015
• Study Start: May 21, 2015
• Primary Completion: October 11, 2016
• Study Completion: October 18, 2016
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

BR (1)