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Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

NCT ID: NCT01795222

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:

* oral midazolam + oral ketamine + inhaled sevoflurane
* oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.

Conditions

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Early Childhood Caries

Keywords

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conscious sedation stress psychological dental care for children child behavior saliva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral Midazolam

Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

placebo

placebo oral syrup twenty minutes before starting the procedure

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Midazolam

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Brand: Dormire (Cristalia, Sao Paulo, Brazil) Magistral formula

Eligibility Criteria

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Inclusion Criteria

* Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion Criteria

* Children presenting with at least one of the following:
* airway obstruction and/or oral breathing;
* recent use of systemic corticosteroids
* needing less than two dental restorations;
* previous dental sedation.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role collaborator

Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Heloisa de Sousa Gomes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heloisa S Gomes, DDS

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Aline C Batista, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Goias

Locations

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Faculty of Dentistry, Federal University of Goias

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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307/2011

Identifier Type: -

Identifier Source: org_study_id