Conditions: Post-Operative Pain
Keywords: Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery or hip/knee replacement surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 357
Healthy volunteers: no

Brief summary:
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg intervention 2: morphine IV PCA
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours intervention 2: 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

Protocol document: