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      Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty : A Randomized, Placebo-controlled Study

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          Abstract

          Complications with IV patient-controlled analgesia include programming errors, invasive access, and impairment of mobility. This study evaluated an investigational sufentanil sublingual tablet system (SSTS) for the management of pain after knee or hip arthroplasty.

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          Most cited references19

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          Multimodal pain management after total joint arthroplasty.

          Adequate postoperative pain control in patients who have undergone total joint arthroplasty allows faster rehabilitation and reduces the rate of postoperative complications. Multimodal pain management involves the introduction of adjunctive pain control methods in an attempt to control pain with less reliance on opioids and fewer side effects. Current research suggests that traditional nonsteroidal anti-inflammatory drugs (NSAIDs) and the associated cyclooxygenase type-2 (COX-2) inhibitors improve pain control in most cases. Nearly all multimodal pain management modalities have a safe side-effect profile when they are added to existing methods. The exception is the administration of DepoDur (extended-release epidural morphine) to elderly or respiratory-compromised patients because of a potential for hypoxia and cardiopulmonary events.
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            Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data.

            This study examines the evidence from published data concerning the adverse respiratory and haemodynamic effects of three analgesic techniques after major surgery; i.m. analgesia, patient-controlled analgesia (PCA), and epidural analgesia. A MEDLINE search of the literature was conducted for publications concerned with the management of postoperative pain. Information relating to variables indicative of respiratory depression and of hypotension was extracted from these studies. Over 800 original papers and reviews were identified. Of these papers, 212 fulfilled the inclusion criteria but only 165 provided usable data on adverse effects. Pooled data obtained from these studies, which represent the experience of a total of nearly 20,000 patients, form the basis of this study. There was considerable variability between studies in the criteria used for defining respiratory depression and hypotension. The overall mean (95% CI) incidence of respiratory depression of the three analgesic techniques was: 0.3 (0.1-1.3)% using requirement for naloxone as an indicator; 1.1 (0.7-1.7)% using hypoventilation as an indicator; 3.3 (1.4-7.6)% using hypercarbia as an indicator; and 17.0 (10.2-26.9)% using oxygen desaturation as an indicator. For i.m. analgesia, the mean (95% CI) reported incidence of respiratory depression varied between 0.8 (0.2-2.5) and 37.0 (22.6-45.9)% using hypoventilation and oxygen desaturation, respectively, as indicators. For PCA, the mean (95% CI) reported incidence of respiratory depression varied between 1.2 (0.7-1.9) and 11.5 (5.6-22.0)%, using hypoventilation and oxygen desaturation, respectively, as indicators. For epidural analgesia, the mean (95% CI) reported incidence of respiratory depression varied between 1.1 (0.6-1.9) and 15.1 (5.6-34.8)%, using hypoventilation and oxygen desaturation, respectively, as indicators. The mean (95% CI) reported incidence of hypotension for i.m. analgesia was 3.8 (1.9-7.5)%, for PCA 0.4 (0.1-1.9)%, and for epidural analgesia 5.6 (3.0-10.2)%. Whereas the incidence of respiratory depression decreased over the period 1980-99, the incidence of hypotension did not. Assuming a mixture of analgesic techniques, Acute Pain Services should expect an incidence of respiratory depression, as defined by a low ventilatory frequency, of less than 1%, and an incidence of hypotension related to analgesic technique of less than 5%.
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              Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data.

              This review examines the evidence from published data concerning the tolerability (indicated by the incidence of nausea, vomiting, sedation, pruritus, and urinary retention), of three analgesic techniques after major surgery; intramuscular analgesia (i.m.), patient-controlled analgesia (PCA), and epidural analgesia. A MEDLINE search of publications concerned with the management of postoperative pain and these indicators identified over 800 original papers and reviews. Of these, data were extracted from 183 studies relating to postoperative nausea and vomiting, 89 relating to sedation, 166 relating to pruritus, and 94 relating to urinary retention, giving pooled data which represent a total of more than 100,000 patients. The overall mean (95% CI) incidence of nausea was 25.2 (19.3-32.1)% and of emesis was 20.2 (17.5-23.2)% for all three analgesic techniques. PCA was associated with the highest incidence of nausea but the emesis was unaffected by analgesic technique. There was considerable variability in the criteria used for defining sedation. The overall mean for mild sedation was 23.9 (23-24.8)% and for excessive sedation was 2.6 (2.3-2.8)% for all three analgesic techniques (significantly lower with epidural analgesia). The overall mean incidence of pruritus was 14.7 (11.9-18.1)% for all three analgesic techniques (lowest with i.m. analgesia). Urinary retention occurred in 23.0 (17.3-29.9)% of patients (highest with epidural analgesia). The incidence of nausea and excessive sedation decreased over the period 1980-99, but the incidence of vomiting, pruritus, and urinary retention did not. From these published data it is possible to set standards of care after major surgery for nausea 25%, vomiting 20%, minor sedation 24%, excessive sedation 2.6%, pruritus 14.7%, and urinary retention requiring catheterization 23%. Acute Pain Services should aim for incidences less than this standard of care.
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                Author and article information

                Journal
                Anesthesiology
                Anesthesiology
                Ovid Technologies (Wolters Kluwer Health)
                0003-3022
                2015
                August 2015
                : 123
                : 2
                : 434-443
                Article
                10.1097/ALN.0000000000000746
                26079801
                60b7560b-5e1c-453a-9e99-def6eb035560
                © 2015
                History

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