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| Name | Class |
|---|---|
| Federal University of Minas Gerais | OTHER |
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Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment
This study was initially planned to investigate three paediatric sedation regimens that also included the following 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Midazolam | Active Comparator | Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure |
|
| placebo | Placebo Comparator | placebo oral syrup twenty minutes before starting the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| child stress | level of salivary cortisol according to the ELISA | At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heloisa S Gomes, DDS | Universidade Federal de Goias | Principal Investigator |
| Aline C Batista, PhD | Universidade Federal de Goias | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Federal University of Goias | Goiânia | Goiás | 74605220 | Brazil |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam |
|
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| sedative safety |
assessed according to the World SIVA adverse sedation event reporting tool |
| during and twenty four hours after the procedure |
| D006571 | Heterocyclic Compounds |