Sedation Versus Protective Stabilization for Pediatric Dental Treatment

PHASE4RecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 30, 2020

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2026

Conditions
Child BehaviorDental Caries in Children
Interventions
DRUG

Ketamine 50 MG/ML

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

DRUG

Midazolam Hcl 2Mg/Ml Syrup

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;

PROCEDURE

Protective stabilization

The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.

Trial Locations (2)

74605220

ACTIVE_NOT_RECRUITING

Dental School - UFG, Goiânia

05508-000

RECRUITING

Dental School - FOUSP, São Paulo

All Listed Sponsors
collaborator

University of Sao Paulo

OTHER

collaborator

King's College London

OTHER

lead

Universidade Federal de Goias

OTHER