NCT00902395

Brief Summary

There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

2.5 years

First QC Date

May 13, 2009

Last Update Submit

January 15, 2015

Conditions

Dental CariesChild BehaviorConscious Sedation Failure During Procedure

Keywords

Preschool children

Outcome Measures

Primary Outcomes (1)

  • Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old

    2 years

Secondary Outcomes (1)

  • Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization

    1 month

Study Arms (3)

Midazolam

ACTIVE COMPARATOR

Oral midazolam

Drug: Midazolam

Midazolam/ketamine

EXPERIMENTAL

Combined midazolam and ketamine

Drug: Midazolam, ketamine

Protective stabilization

OTHER

No drug or placebo administered

Behavioral: Protective stabilization

Interventions

MidazolamDRUG

Oral midazolam 1.0 mg/kg (maximum 20 mg)

Also known as: Dormire, Cristalia, Sao Paulo, Brazil
Midazolam
Protective stabilizationBEHAVIORAL

Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.

Also known as: No drug administered
Protective stabilization
Midazolam, ketamineDRUG

Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)

Also known as: Dormire, Cristalia, Sao Paulo, Brazil, Ketamin S+, Cristalia, Sao Paulo, Brazil
Midazolam/ketamine

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children (ASA PS 1)
  • Children under 36 months old
  • Children presenting early childhood caries
  • Children with no history of dental treatment

You may not qualify if:

  • Lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School

Goiânia, Goiás, 74605220, Brazil

Location

Related Publications (1)

  • Moreira TA, Costa PS, Costa LR, Jesus-Franca CM, Antunes DE, Gomes HS, Neto OA. Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. Int J Paediatr Dent. 2013 May;23(3):207-15. doi: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.

    PMID: 22631626RESULT

MeSH Terms

Conditions

Dental CariesChild Behavior

Interventions

MidazolamKetamine

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesBehavior

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Luciane R Costa, DDS, MS, PhD

    Faculty of Dentistry, Federal University of Goias

    PRINCIPAL INVESTIGATOR

  • Paulo S Sucasas, MD, MS, PhD

    Medical School, Federal University of Goias

    PRINCIPAL INVESTIGATOR

  • Thiago A C Moreira, MD

    Health Sciences Graduate Program, UFG

    STUDY CHAIR

  • Denise E Antunes, DDS, PhD

    Health Sciences Graduate Program, UFG

    STUDY CHAIR

  • Cristiana M Jesus-Franca, DDS, PhD

    Health Sciences Graduate Program, UFG

    STUDY CHAIR

  • Hugo S G Oliveira, MD

    Health Sciences Graduate Program, UFG

    STUDY CHAIR

  • Onofre A Neto, MD, PhD

    Faculty of Medicine, UFG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Faculty of Dentistry

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

May 1, 2012

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

BR(1)