MedTrace Logo

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

NCT03290625 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)

    collaborator UNKNOWN

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Luciane Costa, PhD · Universidade Federal de Goias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Months
Max Age
83 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2019-09-12
Completion
2020-03-05

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290625 on ClinicalTrials.gov