Efficacy of Moderate Sedation for Dental Treatment of Young Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Universidade Federal de Goias.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT00902395
First received: May 13, 2009
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Dental Caries
Child Behavior
Conscious Sedation Failure During Procedure
Drug: Midazolam
Behavioral: Protective stabilization
Drug: Midazolam, ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: June 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midazolam
Oral midazolam
Drug: Midazolam
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Other Name: Dormire, Cristalia, Sao Paulo, Brazil
Experimental: Midazolam/ketamine
Combined midazolam and ketamine
Drug: Midazolam, ketamine
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
Other Names:
  • Dormire, Cristalia, Sao Paulo, Brazil
  • Ketamin S+, Cristalia, Sao Paulo, Brazil
Protective stabilization
No drug or placebo administered
Behavioral: Protective stabilization
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Other Name: No drug administered

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.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902395

Locations
Brazil
Dental School
Goiania, Goias, Brazil, 74605220
Sponsors and Collaborators
Universidade Federal de Goias
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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
  More Information

No publications provided

Responsible Party: Luciane Ribeiro de Rezende Sucasas da Costa, Associate Professor, Faculty of Dentistry, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT00902395     History of Changes
Other Study ID Numbers: UFG SAP 18189
Study First Received: May 13, 2009
Last Updated: October 17, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Goias:
Preschool children

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Ketamine
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on August 28, 2014