Conscious Sedation Clinical Trial
Official title:
Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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