Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial

Abstract

Background: Problems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.

Methods: This was a randomized, open-label, 48-hour non-inferiority study with optional extension to 72 hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic (hip or knee replacement) surgery. The primary outcome measure was the proportion of patients who responded "good" or "excellent" (collectively "success") at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48).

Results: A total of 357 patients received study drug and 78.5% vs. 65.6% of patients achieved PGA48 "success" for SSTS vs. IV PCA MS, respectively, demonstrating non-inferiority (P < 0.001 using the one-side Z-test against the non-inferiority margin) as well as statistical superiority for treatment effect (P = 0.007). Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups; however, SSTS had fewer patients experiencing oxygen desaturations below 95% compared to IV PCA MS (P = 0.028).

Conclusions: Sufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA.

Keywords: adverse events; onset of analgesia; opioid; oxygen desaturation; patient-controlled analgesia; postoperative pain; sublingual; sublingual tablet system; sufentanil.

© 2014 AcelRx Pharmaceuticals Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.

Figures

Figure 1

Sufentanil sublingual tablet system with radio-frequency identification (RFID) patient thumb tag and security tether attached to the bottom of the controller.

Figure 2

Patient disposition flow diagram.

Figure 3

The pain intensity difference to baseline (PID) over the first 8 hours; * P < 0.01.

Figure 4

Kaplan–Meier cumulative event rates for time to termination from the study due to inadequate analgesia (log-rank test P = 0.551)

Figure 5

Percent of patients with oxygen desaturation events; *P = 0.028.