NCT01118884

Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children

Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shahid Beheshti University · Academic / Other
• Sex: All
• Age: 36 Months – 96 Months
• Healthy volunteers: Accepted

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.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
DRUG	Promethazine	Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2010-05-07
• Last updated: 2010-05-07

Locations

1 site across 1 country: Iran