Conditions: Sedation Anxiety Pain
Keywords: procedural sedation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).

Detailed description:

Arms:
arm 1: single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ arm 2: single dose of sublingual Placebo NanoTab™

Interventions: intervention 1: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) intervention 2: Placebo NanoTab™
Intervention descriptions: intervention 1: Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ intervention 2: Single dose of sublingual placebo NanoTab™

Protocol document: