- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00902395
Efficacy of Moderate Sedation for Dental Treatment of Young Children
January 15, 2015 updated by: Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
There is a lack of clinical trials on pediatric dental sedation in children 3 years old and under.
We investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation.
Healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective stabilization without sedative (PS).
One observer scored children's behavior using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session.
Data were analyzed using non-parametric bivariate tests.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Goias
-
Goiania, Goias, Brazil, 74605220
- Dental School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy children (ASA PS 1)
- Children under 36 months old
- Children presenting early childhood caries
- Children with no history of dental treatment
Exclusion criteria:
- Lost to follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Midazolam
Oral midazolam
|
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Other Names:
|
Experimental: Midazolam/ketamine
Combined midazolam and ketamine
|
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
Other Names:
|
Other: Protective stabilization
No drug or placebo administered
|
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
- Study Chair: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 13, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 15, 2009
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 15, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Demineralization
- Tooth Diseases
- Dental Caries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Ketamine
- Midazolam
Other Study ID Numbers
- UFG SAP 18189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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