Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment
Overview
- Phase
- Phase 3
- Intervention
- Promethazine
- Conditions
- Conscious Sedation
- Sponsor
- Shahid Beheshti University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Behavior change
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
sedation
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.
Intervention: Promethazine
Outcomes
Primary Outcomes
Behavior change
Time Frame: during dental treatment which is 30 minutes after drug ingestion
Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.