BridgeMD
Compares treatment options for Child Behavior
Official title Sedation Versus Protective Stabilization for Pediatric Dental Treatment
ClinicalTrials.gov ID: NCT04119180
What this study is testing
What is Ketamine 50 MG/ML?
Ketamine 50 MG/ML is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for child behavior.
Also referred to as Ketamin S, Cristalia, São Paulo, Brazil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in the Brazilian context despite moral questions. The objective of this prospective nonrandomized clinical trial is to evaluate the effectiveness of the use of moderate sedation, compared to the protective stabilization, in the dental care of children with fear / anxiety and / or dental behavior problem, and associated factors.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 7. Healthy volunteers may be eligible.
You may be able to join if
- Children presenting cavities that need dental restoration
- ASA I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example) children (ASA, 2015)
- Medical history without neurological or cognitive impairment
- Children who do not use medicines that may impair cognitive functions
- Children at low risk for airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx)...
You likely can't join if
- Children with positive or definitely positive behavior (Frankl et al. 1962) in the dental examination session
- Non-attendance at the first intervention appointment after three scheduling attempts
- Chronic use of systemic corticosteroids
The study team makes the final eligibility decision.
Where it's taking place
- Goiânia, Goiás, Brazil
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 7 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goiânia, Goiás, Brazil; São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.