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Completed

NCT Number: NCT00902395

Efficacy of Moderate Sedation for Dental Treatment of 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.

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Key information

Conditions

Dental Caries Behavior Child Behavior Conscious Sedation Failure During Procedure Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental School

Goiânia, Goiás, 74605220, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Oral midazolam 1.0 mg/kg (maximum 20 mg)

Other names: Dormire, Cristalia, Sao Paulo, Brazil

Protective stabilization

Behavioral

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

Other names: No drug administered

Midazolam, ketamine

Drug

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

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
May 15, 2009
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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