Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Promethazine
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Behavior change [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dental school of Shahid Beheshti University of Medical Sciences | Tehran | Iran, Islamic Republic of | 19839 |
Sponsors and Collaborators
- Shahid Beheshti University
Investigators
- Principal Investigator: Sedighe Mozaffar, Postgraduate student of Shahid Beheshti Medicine University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 171598