drugset / Trial / NCT02078336
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
RandomizedCrossoverTriple-blindTreatment
Summary
The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability. The primary objectives are: * To assess the level of cooperation during regular dental care using different procedural sedation protocols * To assess patient safety during regular dental care using different sedation protocols * To assess patient comfort and possible side-effects after regular dental care using different sedation protocols
Timeline
- Start
- 2013-12
- Primary completion
- 2025-07
- Completion
- 2025-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atropine | Other / unclassified | 0.25 mg | Intramuscular |
| Comparator | Biperiden | Small molecule | 5 mg | Intramuscular |
| Comparator | Diazepam | Small molecule | 10 mg | Intramuscular |
| Comparator | Lorazepam | Small molecule | 2.5 mg | Oral |
| Subject | Midazolam | Small molecule | 15 mg | Oral |
| Comparator | dehydrobenzperidol | Unknown | 0.000125 ml | Intramuscular |
Indications
No indication recorded.