Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intranasal Dexmedetomidine
DEX-IN · 2 trials · 2 indications
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.
| Arm | Type | Description |
|---|---|---|
| DEX-IN 50 µg | EXPERIMENTAL | Dexmedetomidine Intranasal Spray |
| Fentanyl 50 µg | ACTIVE_COMPARATOR | Intravenous Fentanyl |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| DEX-IN 50mcg | EXPERIMENTAL | DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours. |
| IN Placebo | PLACEBO_COMPARATOR | IN Placebo every 6 hours for 48 hours. |
| Name | Type | Description |
|---|---|---|
| DEX-IN | DRUG | IN Dexmedetomidine + IV placebo |
| Fentanyl | DRUG | IN Placebo + IV Fentanyl |
| Placebo | DRUG | IN Placebo + IV Placebo |
| Intranasal Dexmedetomidine | DRUG | - |
| Intranasal Placebo | DRUG | - |
Inclusion Criteria: * Voluntarily provide written informed consent * Be planned to undergo a selected office-based or outpatient procedure * Be naïve to the planned procedure, i.e. no repeated or revision procedures * Not pregnant or planning to become pregnant, or using appropriate contraceptive m...