Real-world use of the sufentanil sublingual tablet system for patient-controlled management of acute postoperative pain: a prospective noninterventional study

Abstract

Objective: To evaluate the real-life effectiveness, safety, tolerability and patient-reported outcomes (PRO) of the sufentanil sublingual tablet system (SSTS) for postoperative pain management (POPM).

Methods: This prospective, multicenter, noninterventional, study included adults with acute moderate to severe postoperative pain who self-administered sufentanil using the SSTS. Main outcome measures were pain intensity at rest (numerical rating scale [NRS]: 0 [no pain] to 10 [most intense pain imaginable]); most intense pain intensity (0–10); 4-point patient assessment of the pain control method (“excellent”, “good”, “fair”, “poor”); patient satisfaction with the pain control level and the method of administration of pain medication (6-point scale: “extremely satisfied”, “very satisfied”, “satisfied”, “dissatisfied”, “very dissatisfied”, “extremely dissatisfied”). Adverse drug reactions were recorded.

Results: The SSTS reduced resting pain intensity in patients (n = 341) from a mean ± SD NRS score of 5.2 ± 2.3 (at SSTS handover) to 1.8 ± 1.6 (3rd day after handover). The proportion of patients with severe pain (for the PRO measure “most intense pain”) decreased steadily during the 72 hours of treatment. Overall, 87.1% of the patients reported the method of pain control to be “good” or “excellent”; 91.8% reported being “extremely/very satisfied” or “satisfied” with the level of pain control; and 95.9% were at least satisfied with the method of pain medication administration. SSTS safety and tolerability was typical for opioids and as described in the SSTS Summary of Product Characteristics.

Conclusions: The SSTS is a valuable option for real-life POPM and is effective in a wide range of surgical procedures.

Keywords:

• Sufentanil
• sufentanil sublingual tablet system
• Zalviso
• acute postoperative pain
• patient-controlled analgesia
• opioid analgesics

• European Union electronic Register of Post-Authorization Studies (EU PAS Register) number: EUPAS14689

Transparency

Declaration of funding

This trial was funded by Grünenthal GmbH, Aachen, Germany. The authors did not receive any compensation or honoraria for the preparation of this manuscript.

Declaration of financial/other relationships

All investigators have been reimbursed by Grünenthal for additional workload associated with this study.

Esther Pogatzki-Zahn: Relevant financial support related to the Work Under Consideration: Grünenthal Advisory Board activities and lectures, NIT Zeus. Relevant financial activities outside the submitted work: grants (IIT) financial support from Mundipharma GmbH. Lectures and/or advisory board activities within the last 5 years: Merck Sharp & Dohme GmbH; Merck; Mundipharma GmbH; Mundipharma International; Pfizer Deutschland GmbH; Grünenthal, The Medicines Company, Fresenius Kabi, AcelRx. Peter Kranke: received lecture fees from Grünenthal and has provided consultancy on topics not related to the current manuscript. He has been involved in the conduct of the trial as the principal investigator for the study center. Leopold Eberhart: received honoraria for lectures by Baxter GmbH, Fresenius GmbH and for lectures and consulting activities for Grünenthal GmbH, ratiopharm GmbH. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank Robert A. Furlong, PhD and David P. Figgitt, PhD, ISMPP CMPP™, Content Ed Net, for providing editorial assistance in the preparation of this manuscript, with funding from Grünenthal GmbH, Aachen, Germany. We thank all clinics which participated in data collection and all patients.