A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Summary
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.
Timeline
- Start
- 2022-02-14
- Primary completion
- 2023-04-11
- Completion
- 2023-04-12
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Regimen 1 vs Regimen 2 vs Regimen 3; p = 0.016; ANOVA; note: The threshold for statistical significance was p=0.05. NCT05126459 ↗
registry MEAN Regimen 1: 0.05 (0.005 to 0.15) score on a scale MEAN Regimen 2: 0 (0 to 0) score on a scale MEAN Regimen 3: 0 (0 to 0) score on a scale NCT05126459 ↗
registry analysis (superiority test); Regimen 1 vs Regimen 2; p = 0.211; ANOVA; note: The threshold for statistical significance was p=0.05. NCT05126459 ↗
registry analysis (superiority test); Regimen 1 vs Regimen 2 vs Regimen 3; p = 0.374; ANOVA; note: The threshold for statistical significance was p=0.05. NCT05126459 ↗
registry analysis (superiority test); Regimen 1 vs Regimen 2 vs Regimen 3; p = 0.55; ANOVA NCT05126459 ↗
registry analysis (superiority test); Regimen 1 vs Regimen 2 vs Regimen 3; p = 0.16; ANOVA; note: The threshold for statistical significance was p=0.05. NCT05126459 ↗
registry analysis (superiority test); Regimen 1 vs Regimen 2 vs Regimen 3; p = 0.012; ANOVA; note: The threshold for statistical significance was p=0.05. NCT05126459 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meperidine | Unknown | 1.5 mg/kg | Oral |
| Subject | Meperidine | Unknown | 2 mg/kg | Oral |
| Subject | Midazolam | Small molecule | 0.5 mg/kg | Oral |
| Subject | Midazolam | Small molecule | 0.75 mg/kg | Oral |
| Background | Hydroxyzine | Small molecule | 1.5 mg/kg | Oral |
| Background | Hydroxyzine | Small molecule | 2 mg/kg | Oral |
| Background | Nitrous Oxide | Other / unclassified | 30 % | Inhaled |
| Background | Nitrous Oxide | Other / unclassified | 50 % | Inhaled |
| Background | Oxygen | Other / unclassified | 50 % | Inhaled |
| Background | Oxygen | Other / unclassified | 70 % | Inhaled |