A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Status:	Completed
Conditions:	Post-Surgical Pain, Hospital
Therapuetic Areas:	Musculoskeletal, Other
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	April 2012
End Date:	December 2012

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

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.

Inclusion Criteria:

- Male or female patients who are 18 years or older

- Patients who are scheduled to undergo an open abdominal surgery (including
laparoscopic-assisted), total knee or total hip replacement surgery under general
anesthesia or spinal anesthesia that does not include intrathecal opioids during the
operation.

- Post-surgical patients who have been admitted to the PACU and are expected to remain
hospitalized and to have acute post-operative pain requiring parenteral opioids for
at least 48 hours after surgery.

Exclusion Criteria:

- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
hydrocodone per tablet).

- Patients with an allergy or hypersensitivity to opioids

- Female patients who are pregnant or breast-feeding

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