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

NCT03290625 | Completed Phase 4

• 1 other identifier: PV0939-2017
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caries of Infancy; Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Children's behavior according to observational scale

  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 Outcomes (16)

• Acceptance of intranasal administration according to observation

  From the beginning to the end of the intranasal sedative administration, which should less than one minute each

• Memory of the procedure through questionnaire

  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

  From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours

• Salivary melatonin according to 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

  From the beginning to the end of the dental treatment, which should last around 30-40 minutes

Study Arms (2)

DexKet

EXPERIMENTAL

Intranasal DEXMEDETOMIDINE (2.0 mcg/kg, maximum 100 mcg) + KETAMINE (1.0 mg/kg, maximum 100 mg)

Drug: Dexmedetomidine Hydrochloride; Drug: Ketamine Hydrochloride

Dex

ACTIVE COMPARATOR

DEXMEDETOMIDINE (2.5 mcg/kg, maximum 100 mcg)

Drug: Dexmedetomidine Hydrochloride

Interventions

Dexmedetomidine Hydrochloride DRUG

Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection

Dex; DexKet

Ketamine Hydrochloride DRUG

Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection

DexKet

Eligibility Criteria

• Age: 20 Months - 83 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG): collaborator

Study Sites (1)

Dental School

Goiânia, Goiás, 74605220, Brazil

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Luciane Costa, PhD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 25, 2017
• Study Start: November 9, 2017
• Primary Completion: September 12, 2019
• Study Completion: March 5, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

BR (1)