Dental CariesPhase 4NCT00902395
Efficacy of Moderate Sedation for Dental Treatment of Young Children
A Phase 4 study testing Midazolam, Protective stabilization and Midazolam, ketamine in people with Dental Caries and Child Behavior, run by Universidade Federal de Goias at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Child Behavior, Conscious Sedation Failure During Procedure
- What is being tested?
- Midazolam, Protective stabilization and Midazolam, ketamine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children (ASA PS 1)
- Children under 36 months old
- Children presenting early childhood caries
- Children with no history of dental treatment
Who cannot join
- Lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Midazolam, Protective stabilization, Midazolam, ketamine
- Keywords
- Preschool children
- Medical subject headings
- Dental Caries, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormire, Cristalia, Sao Paulo, Brazil
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Protective stabilizationBehavioural
Also called No drug administered
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Midazolam, ketamineDrug
Also called Dormire, Cristalia, Sao Paulo, Brazil, Ketamin S+, Cristalia, Sao Paulo, Brazil
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Oral midazolam Receives: Drug: Midazolam |
| Midazolam/ketamine | Experimental | Combined midazolam and ketamine Receives: Drug: Midazolam, ketamine |
| Protective stabilization | Other | No drug or placebo administered Receives: Behavioral: Protective stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
Measured: 2 years
Secondary outcomes (1)
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
- Investigators
- Luciane R Costa, DDS, MS, PhD, Principal investigator, Faculty of Dentistry, Federal University of GoiasPaulo S Sucasas, MD, MS, PhD, Principal investigator, Medical School, Federal University of GoiasThiago A C Moreira, MD, Study chair, Health Sciences Graduate Program, UFGDenise E Antunes, DDS, PhD, Study chair, Health Sciences Graduate Program, UFGCristiana M Jesus-Franca, DDS, PhD, Study chair, Health Sciences Graduate Program, UFGHugo S G Oliveira, MD, Study chair, Health Sciences Graduate Program, UFGOnofre A Neto, MD, PhD, Study chair, Faculty of Medicine, UFG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902395
- Sponsor's protocol ID
- UFG SAP 18189
- Status last verified
- Jan 2015
- First submitted
- 13 May 2009
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22631626
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
- ClinicalTrials.gov ID
- NCT00902395
- Acronym / sponsor ID
- UFG SAP 18189
- Keywords
- Preschool children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamOral midazolam |
| Midazolam/ketamine | Experimental | Drug: Midazolam, ketamineCombined midazolam and ketamine |
| Protective stabilization | Other | Behavioral: Protective stabilizationNo drug or placebo administered |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children (ASA PS 1)
- Children under 36 months old
- Children presenting early childhood caries
- Children with no history of dental treatment
Key exclusion criteria (1 listed)
- Lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Dormire, Cristalia, Sao Paulo, BrazilOral midazolam 1.0 mg/kg (maximum 20 mg) | Drug | Midazolam |
| Protective stabilizationAlso: No drug administeredChildren will receive a protective stabilization (physical restrain) with sheet fixed with tapes. | Behavioural | Protective stabilization |
| Midazolam, ketamineAlso: Dormire, Cristalia, Sao Paulo, Brazil, Ketamin S+, Cristalia, Sao Paulo, BrazilCombined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK) | Drug | Midazolam/ketamine |
Primary outcome
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
1 secondary outcome
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Results publication: PubMed 22631626Moreira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciane R Costa, DDS, MS, PhD principal investigator
Faculty of Dentistry, Federal University of Goias
Paulo S Sucasas, MD, MS, PhD principal investigator
Medical School, Federal University of Goias
Thiago A C Moreira, MD study chair
Health Sciences Graduate Program, UFG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam, Protective stabilization and Midazolam, ketamine in people with Dental Caries and Child Behavior, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.