Conditions: Pain, Postoperative
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: yes

Brief summary:
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery.

Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Protocol document: