Real-world use of the sufentanil sublingual tablet system for patient-controlled management of acute postoperative pain: a prospective noninterventional study
- 30 October 2019
- journal article
- research article
- Published by Taylor & Francis Ltd in Current Medical Research and Opinion
- Vol. 36 (2), 277-284
- https://doi.org/10.1080/03007995.2019.1681133
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 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. Trial registration: European Union electronic Register of Post-Authorization Studies (EU PAS Register) number: EUPAS14689.Keywords
This publication has 24 references indexed in Scilit:
- Sufentanil Sublingual Tablet System for the Management of Postoperative Pain Following Open Abdominal SurgeryRegional Anesthesia & Pain Medicine, 2015
- Sufentanil Sublingual Tablet System vs. Intravenous Patient‐Controlled Analgesia with Morphine for Postoperative Pain Control: A Randomized, Active‐Comparator TrialPain Practice, 2014
- Correlates of satisfaction with pain treatment in the acute postoperative period: Results from the international PAIN OUT registryPain, 2014
- Procedure-specific Risk Factor Analysis for the Development of Severe Postoperative PainAnesthesiology, 2014
- Pain Intensity on the First Day after SurgeryAnesthesiology, 2013
- Pharmacokinetics of Sublingual Sufentanil Tablets and Efficacy and Safety in the Management of Postoperative PainRegional Anesthesia & Pain Medicine, 2013
- Practice Guidelines for Acute Pain Management in the Perioperative SettingAnesthesiology, 2012
- Übelkeit und Erbrechen nach Operationen in Allgemeinanästhesie - Empfehlungen zur Risikoeinschätzung, Prophylaxe und TherapieAINS - Anästhesiologie · Intensivmedizin · Notfallmedizin · Schmerztherapie, 2011
- Patient-Controlled Transdermal Fentanyl Hydrochloride vs Intravenous Morphine Pump for Postoperative PainJAMA, 2004
- Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probabilityCanadian Journal of Anesthesia/Journal canadien d'anesthésie, 2003