Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children
This trial is active, not recruiting.
|Sponsor||Shahid Beheshti University|
|Start date||June 2009|
|End date||April 2010|
|Trial size||20 participants|
|Trial identifier||NCT01118884, 171598|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||health services research|
time frame: during dental treatment which is 30 minutes after drug ingestion
Male or female participants from 36 months up to 96 months old.
Inclusion Criteria: - Healthy patients who are in ASA class 1 group - Age of the patients must be between 36-96 months - Uncooperative children who are in groups 1 or 2 according to Frankel's classification Exclusion Criteria: - Tonsil hypertrophy - History of allergies - Drooling or nocturnal snoring
|Official title||Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment|
|Principal investigator||Sedighe Mozaffar|
|Description||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.|
Call for more information