Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children
Recruitment status was Active, not recruiting
The purpose of this study is to compare the safety and efficacy of sedation using orally administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children receiving dental treatments.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment|
- Behavior change [ Time Frame: during dental treatment which is 30 minutes after drug ingestion ] [ Designated as safety issue: Yes ]Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
20 healthy uncooperative children aged 36-96 months were examined in a cross-over study design , each patient served as his/her own control. Each patient was assigned randomly to received 1 of 2 drug regimens for initial sedation session and the other regimen administered at second session which was one week later.
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours
The effectiveness of oral midazolam in pediatric dentistry is controversial. Usefulness of midazolam alone is limited to short-duration procedures, and we are needed to identify safe oral conscious regiments which permit longer duration procedures in dental treatments especially in Pediatric dentistry.
Promethazine is a long-acting (4-12 hr) anti-histaminic, H1 antagonist drug which acts as a central nervous system depressant and showing itself to be a weak anxiolytic drug.
The hypothesis to be tested is whether promethazine would improve the patients behavior during dental procedures without affecting vital signs, thus enabling longer periods of moderate or conscious sedation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118884
|Iran, Islamic Republic of|
|Dental school of Shahid Beheshti University of Medical Sciences|
|Tehran, Iran, Islamic Republic of, 19839|
|Principal Investigator:||Sedighe Mozaffar||Postgraduate student of Shahid Beheshti Medicine University|