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A7 [MAY 2014, SUPPLEMENT A] Bariatric Times HOT TOPICS IN SURGICAL PAIN MANAGEMENT morphine consumption over 24 hours when compared to placebo plus standard of care (P<0.05) (Figure 7b). The data in this study suggest that when administered preoperatively, IV acetaminophen 1g demonstrated a significantly greater reduction in morphine consumption compared to the same dose administered intraoperatively (P<0.05). 2 7 While IV acetaminophen has demonstrated the ability to reduce opioid consumption, the clinical significance of this has not been evaluated or demonstrated. Improved Patient Satisfaction With OFIRMEV Patient reports of satisfaction with pain management favor IV acetaminophen plus standard of care over placebo plus standard of care in a number of clinical trials and surgery types. In the study by Wininger and colleagues, patients' global evaluation of satisfaction with study treatment and satisfaction with AEs related to study treatment were reported at 24 hours. These results significantly favored IV acetaminophen plus rescue over the combined placebo plus rescue (all comparisons, P<0.001). 24 Similar results were demonstrated in the study by Sinatra and colleagues; patients' global evaluations of study treatment at 24 hours (repeated doses) were significantly more favorable among patients who received IV acetaminophen plus PCA morphine versus patients who received placebo plus PCA morphine. On a four- point categorical scale, satisfaction scores of good or excellent reported at 24 hours were significantly higher in the IV acetaminophen plus PCA morphine arm over the placebo plus PCA morphine arm (40.8% versus 23.1%, P=0.004). 19 A recent 2013 publication of a pooled analysis of patient satisfaction scores from five RCTs evaluated IV acetaminophen in the acute postoperative setting. 28 The analysis included patient-level data from the two pivotal trials for OFIRMEV, as well as FDA registrational studies in the following surgery types: open abdominal gynecological surgery, vaginal hysterectomy, and hip arthroplasty. In each of these studies, patient satisfaction was measured using a four-point categorical rating scale. The endpoints were excellent satisfaction (primary) and good or excellent satisfaction at 24 hours following first administration of study drug. 28 The analysis concluded that implementing a multimodal analgesic regimen that includes IV acetaminophen results in significantly greater patient satisfaction. Patients who received IV acetaminophen were more than twice as likely as those who received placebo to report excellent satisfaction with study treatment (32.3% versus 15.9%, respectively; P<0.001). 28 Clinical Safety of OFIRMEV The safety of IV acetaminophen has been established by a clinical trial data set comprised of 1,020 adult patients, including 37.3 percent (n=380) who received five or more doses, and 17 percent (n=173) who received more than 10 doses. Most adult patients, 86.9 percent (n=886), were treated with IV acetaminophen 1g every six hours. A total of 13.1 percent (n=134) received IV acetaminophen 650mg every four hours. The most common treatment, emergent AEs (TEAEs), occurring in at least three percent of adult patients treated with IV acetaminophen and at a greater frequency than placebo in repeated-dose studies were nausea, vomiting, headache, and insomnia (Table 1). 16 Healthcare practitioners should be aware that the antipyretic effects of IV acetaminophen may mask fever in patients treated for postsurgical pain. FIGURE 7. Reduced opioid consumption in orthopaedic surgery and abdominal hysterectomy a. Sinatra RS, et al. Anesthesiology. 2005;102:822-831. b. Arici S, et al. Agri. 2009;21:54-61. Note: Opioid consumption reduction is highly dependent on clinical trial design, and the clinical consequence of any amount of opioid consumption reduction may not have been evaluated or demonstrated in a given trial. a b EDITED-Cadence Ofirmez Suppl copy 2_Layout 1 4/14/14 10:14 AM Page A7