IV Tylenol Use in Postoperative Analgesia



IV Tylenol Use in Post Operative AnalgesiaRandall Morris, April Schmidt, Michelle Semmes, Mary Shull & Sara QuainooN312Duke University School of Nursing IV Tylenol Use in Postoperative AnalgesiaIntroductionPostoperative pain results in suffering and can lead to multiple physiological and psychological consequences such as splinting, decreased gastrointestinal mobility, and delayed ambulation leading to increased length of stay. Multimodal analgesia, utilizing non-opioid analgesics, is one approach to decrease opioid consumption and improve postoperative analgesia. The use of multimodal analgesic techniques may result in reduced frequency of opioid-related adverse effects, more effective postoperative pain relief, diminished opioid consumption, and increased patient satisfaction (Smith, 2011). Intravenous Tylenol is a safe and tolerable analgesic with the potential to decrease opioid consumption making it an attractive choice in postoperative pain management (Groudine & Fossum, 2011). The goal of this research utilization project is to answer the question, “In adult surgical patients (P), does the use of IV Tylenol (I), compared to not using IV Tylenol (C), result in less opioid consumption (O) during the first 48 hours of the postoperative period (T)?” (Written by Sara, April, and Michelle, Edited by Mary and Randall)MethodsSee Appendix AAnalysisTen studies were reviewed, and while measurement tools varied, each study showed that the administration of IV acetaminophen decreased the need for postoperative opioid consumption in adult surgical patients. A 2011 study examined the use of IV acetaminophen and its role in decreasing opioid consumption after major orthopedic joint replacement surgery. The study measured pain intensity differences over 24 hours, and the need for rescue medication. Pain intensity differences were statistically significant in favor of IV acetaminophen compared with placebo (Sinatra, et al., 2011). Also in 2011, a randomized double blind, placebo controlled clinical trial performed in 76 women undergoing abdominal hysterectomy examined the analgesic effect of preoperative acetaminophen on opioid consumption, pain scores, and side effects in patients receiving an elective abdominal hysterectomy. The results showed a thirty percent decrease in hydromorphone consumption in the group that received IV acetaminophen during general anesthesia (Moon, Lee, Lee, & Moon, 2011). A double-blinded RCT involving 124 adult female patients undergoing robot-assisted endoscopic thyroidectomies found that the group which received paracetamol had significantly lower pain scores within the first 24 postoperative hours (Hong, Kim, Chung, Yun, & Kill, 2010). Another RCT, which studied 90 adult female patients undergoing total abdominal hysterectomy, showed pain scores in the first 24 hours of the postoperative period to be significantly less in the two groups receiving paracetamol than in the placebo group.? Morphine consumption was reduced in the study groups as well (Arici, Gurbet, Turker, Yavascaoglu, & Sahin, 2009). A double-blind, randomized study examined 99 patients who were given IV propacetamol 2g or IM morphine 10mg or a placebo following surgical removal of third molar teeth. The response to propacetamol was faster and stronger then morphine on first administration and required less rescue opioid medication than the placebo group (Van Aken, Thys, Veekman, & Buerkle, 2004). A double-blind, randomized study comparing effectiveness of non-opioid analgesics for postoperative pain in 80 patients following lumbar microdiscectomy found that VAS pain scores were low in all groups.? Paracetamol VAS scores were not significantly lower then the scores of those in the placebo group (Grundmann, Wornle, Biedler, Kreuer, Wrobel, & Wilhelm. 2006). A systematic review of 16 prospective RCT journal articles, published from 2005 through 2010 in 9 countries, comparing the effects of IV acetaminophen vs. either an active comparator or placebo in adult patients that received general, regional, sedation, or local anesthesia modalities, were reviewed using the Jadad Scale to assess quality of the RCTs. In 12 of 14 of the placebo-controlled RCTs, it was observed that those receiving IV acetaminophen had improved analgesia (Marcario & Royal, 2011). Another systematic search of 36 RCTs with a cumulative total of 3896 patients, assessed efficacy of a single dose of IV paracetamol, with co-administration of opioids, in adult and child postoperative pain relief and intensity. Secondary endpoint analysis focused on the mean difference in a decreased intervention effect from opioid usage. Only 6 of 36 studies described the volume of patients that needed opioid rescue medication. Combined results showed that those receiving placebo required a mean of 1.3 mg more opioid rescue medication than those who received IV paracetamol (McNicol, et. al., 2011). A single-blind controlled study was reviewed which sampled 40 adult patients undergoing complex, major abdominal or pelvic surgery who were randomly determined to receive either IV paracetamol or placebo in conjunction with IV meperidine. Outcomes were measured in the first 24 hours of the postoperative period by meperidine consumption and mean pain scores, resulting in significantly less consumption of IV meperidine in the group that received IV paracetamol (Memis, et al., 2010). Finally, a randomized, double blind, placebo-controlled study, with parallel groups, studied 76 adult patients undergoing elective tonsillectomy to investigate the efficacy, safety, and opioid sparing effects of IV paracetamol during the first 24 hours of the postoperative period. The primary measurement tool was the need for rescue medication (meperidine). Seventy-one percent of patients who received IV paracetamol did not need meperidine and expressed greater satisfaction with pain control (Atef & Fawaz, 2008). Based on the reviewed RCTs and systematic reviews, there is strong evidence to support the hypothesis that the use of IV Tylenol in adult surgical patients in the first 48-hours of the post operative period reduces the consumption of opioids, when compared to placebo. (Written by group)Implementation planBased on the review of the literature, there is a strong recommendation for IV acetaminophen use intraoperatively to decrease opioid consumption. As a result, a practice change will be implemented at Duke University Medical Center over a six-month period to include intraoperative administration of 1 gram of IV acetaminophen during the maintenance phase of anesthesia to adult surgical patients. A change team will be formed and will meet weekly. The team leader will give a presentation during the first meeting on the research findings; as well as the onset, peak, duration, adverse effects, contraindications, and benefits of the drug. During the second weekly change team meeting, a key points sheet will be developed. Information will be disseminated to the anesthesia staff at grand rounds, which is a weekly anesthesia staff meeting where evidence-based research is discussed. The key points sheets will be handed out to those in attendance and emailed to all members of the anesthesia team. Posters promoting the use of IV acetaminophen will be exhibited near medication stations and in the anesthesia break room. Weekly updates will be posted with statistics regarding usage and goals for the next week. The updates will be discussed at weekly change team meetings, as well as weekly grand rounds. (Written by Michelle and April) Environment for changeIn order to assess the environment for change, during the second week, the change team will administer a questionnaire to the staff to assess their feelings about the change (see Appendix B). The clinical expertise and preferences of the staff will be considered, including the discussion of an option to administer the IV acetaminophen at a different stage of the anesthesia process (Moon, Lee, Lee, & Moon, 2011). Acetaminophen is a commonly used drug for patients of all ages, religions, and cultures; therefore few anticipated cultural or religious objections are expected. Patients with any level of liver dysfunction, however, will not be candidates to receive IV acetaminophen intraoperatively during the initial phase of implementation. Resources for implementing the change will jointly be drawn from the budgets of the Departments of Anesthesia, Nursing, and Pharmacy. Marketing costs associated with the change will come from the budget of each department to provide the specialized education for their own personnel. (Written by Mary)Change teamA multidisciplinary change team will be created to ensure effective implementation. The team members will consist of a pharmacist, two anesthesiologists, and two CRNAs. The pharmacist will ensure that there is an adequate supply of IV acetaminophen at all times. Anesthesia providers will be the members of the health team administering the IV acetaminophen. It is critical to gain their support, as well as educate them on the appropriate dose and timing of administration. The members of this team must be stakeholders within their departments to ensure critical support of the change. (Sara, Michelle, April and Mary)Outcomes will be measured on a long-term basis, by the anesthesia review nurse. This nurse will be trained to assess consumption of IV opioids during the first 48-hours of the postoperative period (Memis, et al., 2010) as part of the routine chart review. The anesthesia review nurse will not be a member of the change team to decrease the chance for bias in data collection. All collected data will be objective data from the patients’ charts related to opioid administration and pain responses recorded by bedside nurses. These results will be reported in the weekly grand rounds meeting in order to further support the change implementation. Six months following the implementation of the IV acetaminophen perioperatively, a second questionnaire (Appendix C) will be administered to the staff in order to reevaluate their perspectives of efficacy of the use of IV acetaminophen. The validity and reliability of the questionnaires will be ensured through anonymous responses. (Written by Mary) Change StrategyObjectivesMethod/ planResponsibilityCompletion DateMeasurable outcomes Increase availability of IV acetaminophen to the OR setting. Initial goal: availability for 75% of adult surgical casesCRNA will assess quantity needed. Four weeks prior to implementation date, pharmacy will order an adequate supply of IV acetaminophen and stock this in the OR with current standard drugsPharmacist and CRNA team leader8/24/12Supply of IV acetaminophen was consistently greater than the quantity needed for 75% of adult surgical cases. There were no IV acetaminophen shortages in the first six months of implementation. Increase use of IV Tylenol to 50% of cases in which there are no rm Anesthesia providers of the research findings; as well as the onset, peak, duration, adverse effects, contraindications, and benefits of the drug on patient outcomes. CRNAs/ Anesthesiologists12/10/12A quality improvement form will be provided for every case and the anesthesia provider will document if IV Tylenol has been administered or not. Percentage of usage will be calculated weekly and reports will be provided. (Written by Sara, edited by group)Resources/Budget/TimelineResources needed for the implementation of the use of IV acetaminophen perioperatively include the drug itself, administration supplies, education and marketing materials for each department, costs of labor time for the change team, as well as the staff as they are educated on the practice change. According to a July 19, 2010 video transcript of surgery at Duke, it was estimated that “more than 30,000 surgeries are performed each year” at Duke Medical Center (Sowers, 2010). Our change strategy will realize increases in IV Tylenol availability for 75% of the surgeries performed annually at Duke. Budgeting will occur on a quarterly basis at a rate of approximately 5,600 surgeries quarterly with secondary goal to increase use of IV acetaminophen in up to 50% of surgical cases with no contraindications. According to a June 2011 University of Utah Hospitals and Clinics Pharmacy Bulletin, the average wholesale price (AWP) for IV Tylenol “is $309.60 for 100 mL vials in packages of 24, or $12.90 for each single-use 100 mL vial” (Healthcare Utah, 2011). Staffing costs will be billed at the discipline specific hourly wage accrual rate to account for the Change Team membership (Appendix D). The six-month implementation timeline (Appendix E) will allow all departments adequate time to train their staff and incorporate the practice change into their own practice. (Written by Randall)ReferencesArici, S., Gurbet, A., Turker, G., Yavascaoglu, B., & Sahin, S. (2009). Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri, 21(2), 54-61. Atef, A., & Fawaz, A. (2008). Intravenous paracetamol is highly effective in pain treatment after tonsillectomy in adults. European Archives of Otorhinolaryngology, 265(3), 351-355. Groudine, S., & Fossum, S. (2011). Use of intravenous acetaminophen in the treatment of postoperative pain. J Perianesth Nurs, 26(2), 74-80. Grundmann, U., Wornle, C., Biedler, A., Kreuer, S., Wrobel, M., & Wilhelm, W. (2006). The efficacy of the non-opioid analgesics Parecoxib, Paracetamol, and Metamizol for postoperative pain relief after lumbar microdiscectomy. Anesthesia and Analgesia, 103, 217-222. Hong, J. Y., Kim, W. O., Chung, W. Y., Yun, J. S., & Kil, H. K. (2010). Paracetamol reduces postoperative pain and resuce analgesic demand after robot-assisted endoscopic thyroidectomy by the transaxillary approach. World J Surg, 34(3), 521-526. Marcario, A., & Royal, M. (2011). A literature review of randomized clinical trials of intravenous acetaminophen (Paracetamol) for acute postoperative pain. Pain Practice, 11(3), 290-296. McNicol, E., Tzortzopoulou, A., Cepeda, M., Francia, M., Farhat, T., & Schumann, R. (2011). Single -dose intravenous Paracetamol or Propracetamol for prevention or treatment of postoperative pain: A systematic review and meta-analysis. British Journal of Anaesthesia, 106(6), 764-765. Memis, D., Inal, M., Kavalci, G., Sezer, A., & Sut, N. (2010). Intravenous paracetamol reduced the use of opioids, extubation time, and opioid-related adverse effects after major surgery in intensive care unit. Journal of Critical Care, 25(3), 458-462. Moon, Y. E., Lee, Y. K., Lee, J., & Moon, D. E. (2011). The effects of preoperative intravenous acetaminophen in patients undergoing abdominal hysterectomy. Arch Gynecol Obstet, 284(6), 1455-1460. Sinatra, R. S., Jahr, J. S., Reynolds, L., Groudine, S. B., Royal, M. A., Breitmeyer, J. B., & Viscusi, E. R. (2011). Intravenous acetaminophen for pain after major orthopedic surgery. Pain Practice. Smith, H. S. (2011). Perioperative intravenous acetaminophen and NSAIDs. Pain Med, 12(6), 961-981. Sowers, K. (COO). (2008). Your Surgery at Duke Medicine [Marketing Video]. Video March 17, 2012, posted to Web site: http:/?/??health_library/?video/?your_surgery_at_duke_medicine/?article_viewVan Aken, H., Thys, L., Veekman, L., & Buerkle, H. (2004). Assessing analgesia in single and repeated administrations of propacetamol for postoperative pain: Comparison with morphine after dental surgery. Anesthesia and Analgesia, 98, 159-165.Appendix A: MethodsA search using PubMed, Google Scholar, CINAHL, the National Library of Sciences via the FDA Biosciences Library, and the website was performed using a combination of specific search terms to yield free access to full-text meta-analysis and integrative research reviews. Search terms included: “acetaminophen”; “analgesics, non-steroidal”; “pain, postoperative management”; “analgesics, non-narcotic”; “anti-inflammatory agents, non-steroidal”; “IV acetaminophen”; “opioids”; “IV Tylenol”; “placebo”; “reduced opioid AND postoperative”; “IV Tylenol compared to placebo”; “IV acetaminophen AND opioids”; and “meta-analysis”. In addition, reference lists from articles retrieved and articles identified on the website were searched to determine if they satisfied our PICOT research question. Results were culled by each team member during the search process based on the presence of the following inclusion criteria: adult surgical patients, IV Tylenol use as opposed to other routes of administration, measured opioid consumption, and articles less than 10 years old. Articles were excluded if they met the following criteria: non-surgical population, non-adult population, articles not available in the English language, non-human studies, and articles not available in full text. Search results yielded less than 25 integrative reviews and very few meta-analyses that were deemed to include the key elements of our PICOT and inclusion criteria. Most data relied upon in our analysis included randomized control trials (RCTs). A review of the meta-analyses available revealed that the authors were not able to pool efficacy results across the research articles because of uncontrolled variations in the variables including dosing regimen and primary endpoint pain scores. (Written by Randall, Edited by Group)Appendix B: Pre-implementation questionnaireThis questionnaire, related to IV acetaminophen, is to be submitted anonymously to the labeled box in the OR staff lounge. 1) How often do you administer IV acetaminophen intraoperatively as part of your pain management regimen? 2) If evidence was presented showing the benefit of using IV acetaminophen, would you be willing to use it? 3) If not, why not? 4) What are the barriers to using IV acetaminophen? Appendix C: Post-implementation Questionnaire This questionnaire, related to IV acetaminophen, is to be submitted anonymously to the labeled box in the OR staff lounge. 1) How often do you administer IV acetaminophen intraoperatively as part of your pain management regimen? 2) Do you believe evidence (both published literature and your own experience) is sufficient to include IV acetaminophen in your practice? 3) If not, why not? 4) What are the barriers to using IV acetaminophen? Appendix D: BudgetPROGRAM ITEMFY 2013, 1st QtrFY 20132nd QtrFY20133rd QtrFY20134th Qtr.EXPENSES:Personnel costs (salary and benefits at hourly rate)Clinical PharmacistAnesthesiologist (2)CRNAs (2)Total Personnel Costs$1,322.46$3,461.54$12,047.77$16,831.77Duke Medical Center Surgery and Nursing Department Marketing ActivitiesPostersFlyersTotal Marketing Activities$200$100$300SuppliesIV Tylenol for 5,600 Quarterly SurgeriesTotal Supplies$72,240$72,240Staff Education15 minute training for each OR staff member$2,103.36TOTAL EXPENSES$91,475.13REVENUETOTAL REVENUE$0(Written by Mary)Appendix E: TimelineTaskCompletion DateFirst weekly change team meeting: Present evidence to change team7/2/12Second weekly change team meeting: Development of key points sheet for anesthesia staff7/9/12Distribution of key points sheet to staff at grand rounds7/16/12Distribution of pre-implementation questionnaire7/13/12Due: 7/20/12Pre-implementation questionnaires reviewed by change team7/23/12Training will be completed by departments related to dosage, administration, timing, etc.8/17/12Posters and administration reminders with published “go live” date will be posted in OR lounge and near medication sources8/20/12Pharmacy will obtain, stock and barcode IV acetaminophen for OR use with supply for 75% of adult surgical cases8/24/12“Go live” date for pilot implementation9/3/12Evaluation of weekly administration and opioid consumption dataWeekly: 9/10/12 through 12/10/12Data collection by anesthesia review nurse9/3/12 through 12/10/12Implementation goal: IV acetaminophen administration in at least 50% of adult surgical cases12/10/12Distribution of post-implementation questionnaire12/10/12Due 12/16/12Evaluation of post-implementation questionnaire12/17/12Presentation of findings to OR staff and hospital administration12/28/12Change team meeting to evaluate process and discuss need for process improvements and/or more widespread implementation1/7/13(Written by Mary) ................
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