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Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

NCT01795222 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-12-04

No results posted yet for this study

Summary

Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

Conditions

  • Early Childhood Caries

Interventions

DRUG

Midazolam

Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist

DRUG

Placebo

Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Sponsors & Collaborators

  • Federal University of Minas Gerais

    collaborator OTHER

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Heloisa S Gomes, DDS · Universidade Federal de Goias

  • Aline C Batista, PhD · Universidade Federal de Goias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT01795222 on ClinicalTrials.gov