Sufentanil Sublingual Tablet System Research Articles

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery.

Patient-controlled analgesia (PCA) is commonly used for postoperative pain control. Although widely used, intravenous (IV) morphine PCA may not be suitable for all patients. Sufentanil sublingual tablet system (SSTS) PCA is a recent technique that has had success as a safe and effective alternative for acute pain management. This study aims to compare both the efficacy and safety of SSTS PCA versus IV morphine PCA in postoperative pain control and the quality of recovery in adult patients following scheduled gynecological or orthopedic surgery. Open-label, parallel-group, randomized controlled trial with 54 patients. The primary outcome was postoperative pain control, while the secondary outcomes included adverse effects associated with two analgesic modalities, total opioid dose required, patient satisfaction, and impact on the quality of postoperative recovery. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 26.0 (Released 2019; IBM Corp., Armonk, New York, United States). The chi-squared test was used in categorical variables. When distribution was normal, T-student (mean ± standard deviation) was used in continuous variables. In contrast, when distribution was not normal, the Mann-Whitney test (median (minimal-maximal)) was used. The results showed that there was a statistically significant difference in the total dose of opioid used by patients at 24 hours postoperatively, with patients receiving SSTS PCA requiring a higher total dose when compared to those receiving IV morphine PCA. However, there were no statistically significant differences in pain scores, adverse events, or patient satisfaction. The study suggests that both IV morphine and sublingual sufentanil are safe and effective for postoperative pain management.

Patient-controlled sublingual sufentanil tablet system versus intravenous opioid analgesia for postoperative pain management after lumbar spinal fusion surgery

PurposeThis retrospective cohort study investigated the efficacy of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient-controlled analgesia (IV-PCA) with piritramide for the management of postoperative pain following lumbar spinal fusion surgery.MethodsThis was a retrospective analysis of patients undergoing single- or two-level lumbar spinal fusion surgery and receiving the SSTS or IV-PCA for postoperative pain relief as part of multimodal pain management that included IV paracetamol and oral metamizole. The following variables were collected: postoperative pain intensity and frequency scores using the numerical rating scale (NRS), hospital anxiety and depression scale (HADS), occurrence of nausea, postoperative mobilization, and patient satisfaction (MacNab criteria).ResultsSixty-four patients were included. Those receiving the SSTS (n = 30) had significantly lower pain intensities on the operative day (NRS: 4.0, CI: 3.6–4.3 vs. 4.5, CI: 4.2–4.9; p < 0.05) and one day postoperatively (NRS: 3.4, CI: 3.1–3.8 vs. 3.9 CI: 3.6–4.3; p < 0.05) compared to patients receiving IV-PCA (n = 34). No differences were observed on postoperative days 2 to 5. SSTS patients experienced more nausea than IV-PCA patients (p = 0.027). Moreover, SSTS patients had a higher percentage of early mobilization following surgery than IV-PCA patients (p = 0.040). Regarding patient satisfaction, no significant differences were seen between the groups.ConclusionThe SSTS is a potentially advantageous alternative to opioid IV-PCA for use within a multimodal approach to managing postoperative pain after lumbar fusion surgery. Furthermore, the potentially higher emetic effect of SSTS should be considered, and the patient should be able to perform the application.

Sufentanil sublingual tablet system for enhanced recovery after total knee arthroplasty: a prospective observational case study

BackgroundPostoperative pain is one of the main factors that delays recovery after prosthetic knee surgery. The use of sufentanil sublingual tablet systems (SSTS) can effectively relieve postoperative pain, but their value in facilitating early mobilization has been little studied so far. Our aim here was to assess whether their use could facilitate recovery after knee arthroplasty in an enhanced recovery program.Case presentationIn a prospective observational single-center study, thirty patients operated on for primary knee arthroplasty in the enhanced recovery pathway were included. Patients who received the SSTS (n=15) were compared with those who received an intravenous morphine patient-controlled analgesia (PCA) (n=15). Our recovery program included in particular the use of an adductor canal block, periarticular infiltration of local anesthetic by the surgeon, removal of the venous cannula from the recovery room if possible, the use of an SSTS when available or an IV morphine PCA otherwise, and early physiotherapy. Recovery parameters including the Timed-Up and Go test, pain scores at rest and on exertion, knee flexions, complications, and lengths of hospital stay were not significantly different between the two groups. However, the postoperative opioid consumption in morphine equivalents was significantly greater in the SL-sufentanil group and these patients had their venous cannula removed earlier than in IV-morphine group.ConclusionIn our center, the use of a SSTS was suitable for treating postoperative pain after knee arthroplasty, but it did not improve early recovery in comparison with a morphine PCA.

Sublingual Sufentanil versus Standard-of-Care (Patient-Controlled Analgesia with Epidural Ropivacaine/Sufentanil or Intravenous Morphine) for Postoperative Pain Following Pancreatoduodenectomy: A Randomized Trial.

BackgroundThe optimal treatment strategy for postoperative pain following pancreatoduodenectomy remains unknown. The aim of this study was to investigate whether sublingual sufentanil tablet (SST) is a non-inferior analgesic compared to our standard-of-care (patient-controlled epidural analgesia [PCEA] or PCA morphine) in the treatment of pain following pancreatoduodenectomy.MethodsThis was a pragmatic, strategy, open-label, non-inferiority, parallel group, randomized (1:1) trial. The primary outcome was an overall mean pain score (Numerical Rating Scale: 0–10) on postoperative days 1 to 3 combined. The non-inferiority margin was −1.5 since this difference was considered clinically relevant.ResultsBetween October 2018 and July 2021, 190 patients were assessed for eligibility and 36 patients were included in the final analysis: 17 patients were randomized to SST and 19 patients to standard-of-care. Early treatment failure in the SST group occurred in 2 patients (12%) due to inability to operate the SST system and in 2 patients (12%) due to severe nausea despite antiemetics. Early treatment failure in the standard-of-care group occurred in 2 patients (11%) due to preoperative PCEA placement failure and in 1 patient (5%) due to hemodynamic instability caused by PCEA. The mean difference in pain score on postoperative day 1 to 3 was −0.10 (95% CI −0.72–0.52), and therefore the non-inferiority of SST compared to standard-of-care was demonstrated. The mean pain score, number of patients reporting unacceptable pain (pain score >4), Overall Benefit of Analgesia Score, and patient satisfaction per postoperative day, perioperative hemodynamics and postoperative outcomes did not differ significantly between groups.ConclusionThis first randomized study investigating the use of SST in 36 patients following pancreatoduodenectomy showed that SST is non-inferior compared to our standard-of-care in the treatment of pain on postoperative days 1 to 3. Future research is needed to confirm that these findings are applicable to other settings.

Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery.

Aim: To evaluate the usability and satisfaction from the sufentanil sublingual tablet systemanalgesia in the Enhanced Recovery After Surgerypathway in patients, nurses and physical therapist. Materials & methods: A system usability scalewas used to evaluate analgesia system in the prospective observational study in spine, orthopedic and thoracic patients. Result:In 111 cases the median system usability scale score was 90 (80-100) (patients) and 72.5 (57.5-82.5)(nurses). The median satisfaction score of the physiotherapist was 90 (75-100). Conclusion: The usability and the satisfaction of the patients and the caregivers from sufentanil sublingual tablet system analgesia in the context of Enhanced Recovery After Surgery protocol were good-to-excellent. The economic potential in the reduction of hospital stay should be studied. Trial registration number: NCT03373851(ClinicalTrial.gov).

Efficacy and safety of sufentanil sublingual tablet system in postoperative pain management: a systematic review and meta-analysis

BackgroundSufentanil sublingual tablet system (SSTS) is a recently approved formulation for postoperative pain management that has become popular due to its pharmacokinetic properties such as good bioavailability, rapid attainment of...

Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study

PurposeEffectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol.MethodsThis pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10 mg twice daily and oral oxycodone immediate-release 5 mg up to four times daily on demand (Oxy group) to control pain during 48 h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24 h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded.ResultsMedian pain score at 24 h at rest was 3 [2–4] for Oxy group vs 2 [1.75–3] for SSTS group (p = 0.272) whereas median pain score on movement was 4 [3–6] vs 3 [2–5] respectively (p = 0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p = 0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181).ConclusionsIn complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty.Trial registrationClinical Trials: NCT04448457; retrospectively registered on June 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3

Sufentanil Sublingual Tablet System: from rationale of use to clinical practice

The control of post-operative pain in Italy and other western countries is still suboptimal. In recent years, the Sufentanil Sublingual Tablet System (SSTS; Zalviso; AcelRx Pharmaceuticals, Redwood City, CA, USA), which is designed for patient-controlled analgesia (PCA), has entered clinical practice. SSTS enables patients to manage moderate-to-severe acute pain during the first 72 postoperative hours directly in the hospital setting. However, the role of SSTS within the current framework of options for the management of post-operative pain needs to be better established. This paper presents the position on the use of SSTS of a multidisciplinary group of Italian Experts and provides protocols for the use of this device.

Sublingual sufentanil tablet system for the management of acute postoperative pain in a hospital setting: an observational study.

The use of a strong opioid with intravenous patient-controlled analgesia (IV-PCA) is recommended for postoperative pain, but its use is restricted due to technical problems. Other delivery systems, like sublingual PCA, with the sufentanil tablet system (SSTS) device, could overcome the safety concerns related to IV-PCA. This prospective observational study evaluated the efficacy, safety and usability of SSTS for post-surgical analgesia in the real-life setting. Two-hundred-ninety-eight subjects (125 males), ranging 18-87 years who were undergoing a surgical intervention with a necessity for postoperative analgesia in a hospital setting, were analyzed for SSTS efficacy and safety. The primary end point (success of treatment according to Patient Global Assessment of the Method of Pain Control [PGA] on the second postoperative day) was achieved in 89.8% (95% CI: 85.6-93.1%, P≤0.001 from a presumed value of 60%). During the first 24 hours, pain was below the baseline score (1.2±1.4 after four hours and 1.8±1.6 after 20 hours). The mean impairment in quality of sleep was 1.7±1.7 on postoperative day 1. The overall nurse ease of care (EOC) and nurses' satisfaction questionnaire score was 4.6±0.6, and 4.1±0.9, respectively. The overall patient EOC score was 4.3±0.5; 93.5% patients were extremely satisfied/satisfied with pain control and 93.2% were extremely satisfied/satisfied with the way of the administration. Under a real-life clinical practice setting, SSTS provides effective pain management and is easy to use for patients and nurses.

Sublingual Sufentanil Tablet System Versus Continuous Morphine Infusion for Postoperative Analgesia in Cardiac Surgery Patients

To assess the effectiveness and side effects of a patient-controlled sublingual sufentanil tablet system for postoperative analgesia after cardiac surgery and to compare it to a nurse-controlled continuous morphine infusion. Prospective, open-label, randomized controlled trial. Single university academic center. Adult patients undergoing cardiac surgery, which included a sternotomy. Sublingual sufentanil tablet system versus nurse-controlled continuous morphine infusion. A total of 483 cardiac surgery patients were screened for eligibility, of whom 64 patients completed the study. No statistically significant differences were found for baseline characteristics between both groups. All mean numeric rating scale (NRS) pain scores from after extubation until intensive care unit discharge were ≤3 in both groups. The cumulative mean NRS pain score from 24 hours after extubation (primary outcome) (t = hours after extubation) was significantly different in favor of the morphine group: (t = 0-24) (0.8 [0.7] v 1.3 [0.8]; p = 0.006). Later cumulative mean pain scores were also in favor of the morphine group: (t = 24-48) (0.2 [0.3] v 0.6 [0.5]; p = 0.001) and (t = 48-63) (0.0 [0.0] v 0.1 [0.2]; p = 0.013). The cumulative opioid dose (in milligrams intravenous morphine equivalents) was significantly higher in the morphine group compared with the sublingual sufentanil group (241.94 [218.73] v 39.84 [21.96]; p = 0.0001). No differences were found for the incidences of postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension between both groups (secondary outcomes). Despite resulting in statistically significantly higher pain scores, a patient-controlled sublingual sufentanil tablet system offers adequate analgesia after cardiac surgery and reduces opioid consumption when compared with continuous morphine infusion.

An up-to-date overview of sublingual sufentanil for the treatment of moderate to severe pain

ABSTRACT Introduction Sufentanil is a selective µ-opioid agonist, used intravenously and intrathecally for moderate to severe acute pain. Sublingual sufentanil nanotablets have been developed; 15 mcg tablet for a patient-controlled analgesia device and 30-mcg tablet for a single-dose device administered by a healthcare professional. Dosing interval is a minimum of 20 min for a 15 mcg tablet and a treatment duration of up to 72 hours. The single 30-mcg nanotablet dosing interval is 1 hour. Mean plasma elimination half-life is 13 hours and bioavailability 47–57% after the first sublingual sufentanil tablet. Areas covered This review focuses on the effectiveness, safety, and feasibility of sublingual sufentanil 30-mcg single dose suspended by a healthcare professional for the management of moderate to severe acute pain. A few Phase 4 studies concerning the sublingual sufentanil tablet system containing 15-mcg nanotablets are also reviewed. Expert opinion Sufentanil sublingual 30-mcg nanotablets provide effective pain relief in various acute moderate to severe pain states. The safety profile of sublingual sufentanil 30 mcg is typical to opioids nausea, vomiting, and sedation being the most common ones. Sublingual sufentanil 30-mcg nanotablet has the potential for efficient moderate to severe pain management in supervised healthcare facilities.

Sufentanil Sublingual for Acute Post-Operative Pain: A Systematic Literature Review Focused on Pain Intensity, Adverse Events, and Patient Satisfaction.

ContextPain is commonly experienced among patients after surgical procedures. Clinical pain management after surgery is far from being successful. Patients may control postoperative pain by self-administration of intravenous opioids using devices designed for this purpose (patient-controlled analgesia or PCA). PCA devices have been developed including the sufentanil sublingual tablet system (SSTS). A systematic review of the use of SSTS for postoperative pain is needed to identify an alternative method of pain management.ObjectivesTo systematically review literature to establish the efficacy and the safety of PCA with SSTS used in the treatment of moderate-to-severe acute post-operative pain in a hospital setting.MethodsEmbase, MEDLINE, Google Scholar, and Cochrane Central Trials Register were systematically searched in December 2019 for studies examining SSTS for pain in adult after surgical procedures. The methodological quality of the studies and their results were appraised using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist and specific measurement properties criteria, respectively.ResultsSixteen studies evaluating SSTS were included for a total of 2311 patients. All participants in the SSTS group reported NRS ≤ 4 within 24 h after surgery. Patient satisfaction was high, with a minimum of 70% satisfaction among patients treated with SSTS. The most common adverse events (AEs) overall for SSTS 15 and 30 mcg were nausea, vomiting, and headache. AEs observed in the studies were generally consistent with those associated with opioids and the postsurgical setting.ConclusionsSSTS is an important system for the management of moderate-to-severe acute pain in a hospital setting. SSTS is well tolerated, with no unexpected adverse events (AEs) and no clinically meaningful vital sign changes. These data confirm the safety and tolerability of the SSTS. Successful pain management resulted in a high level of acceptance of the SSTS by patients with high satisfaction for the method of pain control.

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

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.

The Statistical Analyses Of The Study "Sufentanil Sublingual Tablet System (SSTS) For The Management Of Postoperative Pain After Major Abdominal And Gynecological Surgery Within An ERAS Protocol: An Observational Study" [Response To Letter

The Statistical Analyses Of The Study "Sufentanil Sublingual Tablet System (SSTS) For The Management Of Postoperative Pain After Major Abdominal And Gynecological Surgery Within An ERAS Protocol: An Observational Study" [Response To Letter] Stefano Turi, Francesco Deni, Gaetano Lombardi, Marilena Marmiere, Francesco Giuseppe Nisi, Luigi Beretta Dipartimento di Anestesia, Ospedale San Raffaele, Milano, ItalyCorrespondence: Stefano TuriDepartment of Anesthesiology, Vita-Salute, University, San Raffaele Hospital, Via Olgettina 60, Milan 20132, ItalyTel + 39 02 2 643 2656Email turi.stefano@hsr.it Dear editor We thank Wang and Miao1 for their interest in our recent publication2 and the appreciation of our work. We agree with them on the need of using repeated-measures analysis to evaluate pain intensity at different timepoints. We acknowledge that, for the sake of brevity, our manuscript did not properly clarify the statistical methods used for the analysis and we take this opportunity to better explain them. We performed a repeated measure analysis of variance (ANOVA) to compare pain intensity on different time points. The analysis resulted statistically significant (p

The statistical analyses of the study "Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study"[Letter

The statistical analyses of the study "Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study"[Letter

Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study.

BackgroundThe Sufentanil Sublingual Tablet System (SSTS) is a new, pre-programmed, noninvasive, handheld system for patient-controlled analgesia (PCA) which may allow a faster postoperative recovery compared with standard PCA. The efficacy of SSTS in controlling pain after open abdominal surgery has already been documented. However, to our knowledge SSTS has never been investigated in patients undergoing major surgery within an Enhanced Recovery After Surgery (ERAS) protocol.MethodsThis observational, retrospective analysis included consecutive patients undergoing elective major abdominal and gynecological surgery. All patients received the SSTS device once they were fully awake and had a good control of pain at the end of the surgery. We analyzed changes in pain intensity according to the numerical rating scale (NRS) throughout the treatment as well as its duration, the number of administrations, and possible related adverse events. Patients were also interviewed to assess their quality of sleep and overall satisfaction with the SSTS device.ResultsThe study included 308 patients. Compared to the first SSTS administration, pain intensity decreased from a median NRS of 6 to 0 at day 3, for an overall reduction of 79%. Results were already statistically significant at postoperative day 1 (p<0.01). Adverse reactions were observed in 62 patients, with nausea being the most frequent (12%), and in 93% of patients SSTS was discontinued because it was considered no longer necessary. Patient satisfaction was high, with 89% of them judging the device as “easy” or “very easy” to use.ConclusionsAlthough the retrospective and observational nature of the study as well as the absence of a comparative group limits the strength of evidence, our results consider SSTS an effective and safe tool for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol.

Sublingual sufentanil tablet system for postoperative analgesia after gynecological surgery.

Gynecological procedures are among the most frequent surgical interventions, and effective postoperative analgesia is associated with improved patient comfort. Despite the efficacy of neuraxial analgesia, limitations and potential complications have led to seek new strategies for pain relief. A novel, pre-programmed, non-invasive, hand-held system (Sufentanil Sublingual Tablet System [SSTS]) displayed good results in the orthopedic setting. However, it has never been applied in gynecological procedures. This retrospective observational case series evaluates receiving SSTS for postoperative analgesia. Data from 42 consecutive patients undergoing open gynecological surgery with Pfannenstiel incision were retrieved from medical charts in two Italian hospitals. The mean age was 49±11 years, and mean BMI was 24.4±4.6 kg/m2. We reported effective relief on both static and dynamic pain all along the perioperative period, with good effect on patient's rehabilitation. Postoperative nausea and vomiting is the most common adverse effect, but the incidence was strongly decreased with medical prophylaxis. SSTS was easy to prepare, use and manage by both patients and care providers. SSTS may be an interesting option for postoperative analgesia in gynecologic procedures. The efficacy in the management of dynamic pain is an interesting outcome that needs to be compared with the other standards of pain management, such as neuraxial techniques. Rigorous studies are required to give conclusive evidence, but this is the first report, to our knowledge, of SSTS use in open gynecologic procedures. Our preliminary experience encourages the routine application of SSTS in gynecologic surgery and will help designing future randomized controlled trials on the topic.

Sufentanil sublingual tablet system (Zalviso®) as an effective analgesic option after thoracic surgery: An observational study.

Introduction:Sufentanil sublingual tablet system (SSTS) (Zalviso®) is a sublingual system for patient controlled analgesia, demonstrated to be an effective strategy for pain control after major abdominal and orthopedic surgery. We present a prospective observational study on the use of SSTS for the management of postoperative pain after thoracic surgery. The aim of this study was to assess the efficacy of Zalviso® in reducing pain scores and increasing respiratory ability during postoperative period.Materials and Methods:There were about 40 patients underwent video assisted thoracoscopy were included in the study. All the enrolled patients signed the informed consent were educated to the use of the device. Pain numeric rating scale values (NRS) were recorded at awakening from anesthesia (T0) and during the next hours, both at rest and with cough. We evaluate the time to obtain a mean NRS value ≤3 and difference in pain scores between first and subsequent measurements as the primary outcomes. The ability to use incentive spirometer and eventual drug adverse effect were evaluated as secondary outcomes.Results:All patients in recovery room experienced moderate to severe pain. Pain score at rest and coughing decreased to a mean NRS value ≤3 (mild pain) respectively after 2 and 6 hours and the pain score difference continued to increase significantly after repeated measurements. 67.5% of patients resumed the original spirometric ability in pod 1; 9.5% in pod 2; 12% in pod 3. Only three patients out of forty (7,5%) experienced nausea; one patient (2,5%) had a vomiting episode.Conclusion:Our study showed SSTS as an effective option for postoperative pain management in thoracic surgery, improving pain scores and respiratory ability.

Sublingual sufentanil (Zalviso) patient-controlled analgesia after total knee arthroplasty: a retrospective comparison with oxycodone with or without dexamethasone.

Postoperative pain is a major problem, especially in orthopedic surgery. Our data suggest suboptimal pain management after total knee arthroplasty. This study evaluated a sufentanil sublingual tablet system (Zalviso) to optimize postoperative pain treatment. This retrospective, single-center, cohort study was conducted between January 2017 and September 2017. Zalviso as standard treatment was compared with a cohort receiving oxycodone (Oxy) immediate release and Oxy extended release and another receiving Oxy immediate release, Oxy extended release, and dexamethasone (Dexa + Oxy). The primary end point, pain intensity, was assessed on a numeric rating scale (NRS). Highest, lowest, and number of NRS scores >7 were collected. Secondary end points included length of hospital stay, nausea, and mobilization on the day of surgery. Patients receiving Dexa + Oxy had a lower lowest-pain intensity on day 0 (median 0, IQR 0–0) when compared to patients receiving Oxy (median 2, IQR 0–3; P<0.0001) or Zalviso (median 2, IQR 0–4; P<0.0001). No differences were observed on day 1 or 2. No differences were observed in highest pain score or number of patients reporting NRS scores > 7. Patients treated with Dexa + Oxy or Zalviso were discharged earlier compared to patients treated with Oxy (P<0.001). Patients treated with Zalviso experienced more nausea compared to other groups on day 0 and day 1 (P<0.001). Patients treated with Dexa + Oxy had a higher percentage of mobilization on the day of surgery compared to Oxy and Zalviso (P<0.001). In conclusion, Zalviso did not improve postoperative pain management in patients undergoing total knee arthroplasty and increased nausea.

Sublingual sufentanil for postoperative pain relief: first clinical experiences.

BackgroundThe sublingual sufentanil tablet system (SSTS) is a novel hand-held patient-controlled analgesia device developed for treatment of moderate-to-severe postoperative pain. Here we present the first results of its clinical use.MethodsAdult patients undergoing major surgery in five hospitals in the Netherlands received the SSTS for postoperative pain relief as part of multimodal pain management that further included paracetamol and a nonsteroidal anti-inflammatory drug (NSAID). The following variables were collected: postoperative pain scores using the 11-point numerical rating score (NRS) at rest, number of tablets used, occurrence of nausea, and patient satisfaction scores.ResultsWe included 280 patients in the study; the majority underwent laparoscopic abdominal (49%) or orthopedic (knee replacement) surgery (34%). The median NRS was 3.5 (interquartile range 2.3–4.0) on the day of surgery, 3.3 (2.3–4.0) on the first postoperative day, and 2.8 (2.0–4.0) on the second postoperative day; pain scores did not differ between surgery types. Mean number of tablets used was 19 (range 0–86). Nausea occurred in 34% of patients, more often in women (45% vs 19%). Overall satisfaction was high in 73% of patients. Satisfaction was correlated with pain relief (p<0.001) and inversely correlated with occurrence of nausea (p=0.01).DiscussionIn this data set obtained under real-life conditions we show that the SSTS effectively managed postoperative pain in abdominal and orthopedic surgeries. Future studies should determine patient populations that benefit most from the SSTS, assess the added values versus intravenous patient-controlled analgesia, and determine the pharmacoeconomics of the system.