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

PHASE4CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

May 21, 2015

Primary Completion Date

October 11, 2016

Study Completion Date

October 18, 2016

Conditions
Child BehaviorDental Caries
Interventions
DRUG

Intranasal ketamine

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

DRUG

Oral ketamine

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

Intranasal midazolam

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

DRUG

Oral midazolam

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

Trial Locations (1)

74605220

Dental School, Goiânia

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

Universidade Federal de Goias

OTHER

NCT02447289 - Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment | Biotech Hunter | Biotech Hunter