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Papers of the Week

Papers: 12 Oct 2019 - 18 Oct 2019

Human Studies, Pharmacology/Drug Development

2020 Feb

Curr Med Res Opin



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


Pogatzki-Zahn E, Kranke P, Winner J, Weyland W, Reich A, Vigelius-Rauch U, Paland M, Löhr T, Eberhart L
Curr Med Res Opin. 2020 Feb; 36(2):277-284.
PMID: 31612723.


: 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). : 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. : 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 (3 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 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. : The SSTS is a valuable option for real-life POPM and is effective in a wide range of surgical procedures. : European Union electronic Register of Post-Authorization Studies (EU PAS Register) number: EUPAS14689.