Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment
Pedsed-I
A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
1 other identifier
interventional
18
1 country
1
Brief Summary
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedDecember 4, 2013
December 1, 2013
9 months
December 19, 2012
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Child behaviour
every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes
sedative safety
during and twenty four hours after the procedure
Study Arms (2)
Oral Midazolam
ACTIVE COMPARATORMidazolam oral syrup 1mg/Kg twenty minutes before starting the procedure
placebo
PLACEBO COMPARATORplacebo oral syrup twenty minutes before starting the procedure
Interventions
Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal de Goiaslead
- Federal University of Minas Geraiscollaborator
Study Sites (1)
Faculty of Dentistry, Federal University of Goias
Goiânia, Goiás, 74605220, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heloisa S Gomes, DDS
Universidade Federal de Goias
- STUDY DIRECTOR
Aline C Batista, PhD
Universidade Federal de Goias
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2012
First Posted
February 20, 2013
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
December 4, 2013
Record last verified: 2013-12