Conditions: Post Operative Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 419
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg intervention 2: Placebo Sufentanil NanoTab PCA System
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours. intervention 2: Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.

Protocol document: