Early Childhood CariesPhase 4Pedsed-INCT01795222
Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment
A Phase 4 study testing Midazolam in people with Early Childhood Caries, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Feb 2013
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries
Who cannot join
- Children presenting with at least one of the following:
- airway obstruction and/or oral breathing;
- recent use of systemic corticosteroids
- needing less than two dental restorations;
- previous dental sedation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry, Federal University of Goias
Goiânia, Goiás, 74605220
About this study
Official title: A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment
Read the detailed description
This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:
- oral midazolam + oral ketamine + inhaled sevoflurane
- oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.
However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.
We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.
- Conditions
- Early Childhood Caries
- Being tested
- Midazolam, Placebo
- Keywords
- conscious sedation, stress psychological, dental care for children, child behavior, saliva
- Medical subject headings
- Stress, Psychological, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Brand: Dormire (Cristalia, Sao Paulo, Brazil)
Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
PlaceboDrug
Also called Magistral formula
Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
| Study group | Role | What they receive |
|---|---|---|
| Oral Midazolam | Active comparator | Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure Receives: Drug: Midazolam |
| placebo | Placebo comparator | placebo oral syrup twenty minutes before starting the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
child stress
level of salivary cortisol according to the ELISA
Measured: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion
Secondary outcomes (2)
Child behaviour
child dental treatment is video recorded and then a masked observer watches the videos and categorize child behavior according to the Ohio State University Behavioral Rating Scale (OSUBRS)
Measured: every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes
sedative safety
assessed according to the World SIVA adverse sedation event reporting tool
Measured: during and twenty four hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Responsible party
- Principal investigator, Heloisa de Sousa Gomes, Universidade Federal de Goias
- Investigators
- Heloisa S Gomes, DDS, Principal investigator, Universidade Federal de GoiasAline C Batista, PhD, Study director, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795222
- Sponsor's protocol ID
- 307/2011
- Acronym
- Pedsed-I
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2012
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
- ClinicalTrials.gov ID
- NCT01795222
- Acronym / sponsor ID
- Pedsed-I / 307/2011
- Conditions
- Early Childhood Caries
- Keywords
- conscious sedation, stress psychological, dental care for children, child behavior, saliva
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Feb 2013 (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.
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment
Detailed description
This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:
- oral midazolam + oral ketamine + inhaled sevoflurane
- oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.
However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.
We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Midazolam | Active comparator | Drug: MidazolamMidazolam oral syrup 1mg/Kg twenty minutes before starting the procedure |
| placebo | Placebo comparator | Drug: Placeboplacebo oral syrup twenty minutes before starting the procedure |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries
Key exclusion criteria (5 listed)
- Children presenting with at least one of the following:
- airway obstruction and/or oral breathing;
- recent use of systemic corticosteroids
- needing less than two dental restorations;
- previous dental sedation.
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: Brand: Dormire (Cristalia, Sao Paulo, Brazil)Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist | Drug | Oral Midazolam |
| PlaceboAlso: Magistral formulaMagistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam | Drug | placebo |
Primary outcome
child stress
Time frame: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion
level of salivary cortisol according to the ELISA
2 secondary outcomes
Child behaviour
Time frame: every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes
sedative safety
Time frame: during and twenty four hours after the procedure
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 4 Dec 2013.
Related trials for Early Childhood Caries
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Active, not recruitingPhase 2
Povidone Iodine Efficacy Study
Early Childhood Caries
RecruitingObservational study
Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia
Pediatric Dental General Anesthesia, Restoration
Not yet recruiting
WhatsApp Messages to Improve Mothers' Oral Health Knowledge and Children's Toothbrushing
Oral Health, Dental Caries
RecruitingObservational study
Analysis of Salivary Proteins in Young Children as an Device to Improve Caries Risk Assessment
Early Childhood Caries (ECC)
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.
Heloisa S Gomes, DDS principal investigator
Universidade Federal de Goias
Aline C Batista, PhD study director
Universidade Federal de Goias
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 in people with Early Childhood Caries, 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 1 inclusion and 5 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 4 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
child stress (time frame: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2013.