Does The Use of Ethyl Chloride Improve Patient-Reported Pain Scores With Negative Pressure Wound Therapy Dressing Changes? A Prospective, Randomized Controlled Trial.

BACKGROUND: Negative pressure wound therapy (NPWT) is commonly used for surgical incisions and large wounds, particularly in the context of trauma. Research has shown that patients report that the most painful aspect of NPWT is related to foam dressing changes. This study aimed to determine whether topical use of the vapocoolant anesthetic ethyl chloride would impact patient-reported pain during these procedures. METHODS: This study was a single-blinded, placebo-controlled randomized trial in patients who were undergoing NPWT foam dressing change following surgery performed by the orthopedic trauma team. A total of 100 patients were randomized to receive ethyl chloride topical anesthetic spray or placebo (tissue culture grade water) during dressing change. The outcome measure specified prior to enrollment was a mean decrease in patient-reported pain of 1.7 points using a numeric rating scale. Baseline and procedural characteristics were collected to investigate contributions to patient-reported pain. We hypothesized that the use of ethyl chloride would decrease patient reported pain scores. RESULTS: Significantly more females were randomized to the receive vapocoolant; remaining baseline and procedural characteristics were similar between groups. The median time for NPWT drape removal was 2.0 minutes in both groups (p = 0.66). The postprocedural pain reported by patients was significantly lower in the experimental group compared with placebo (median, 5.0 vs. 7.0; p = 0.03). Multivariate analysis adjusting for potential confounders showed treatment group to be the strongest predictor of postprocedure pain (p = 0.002). Additionally, a generalized linear model suggests that treatment group was the strongest predictor of change in pain score as reported by patients prior to and immediately following dressing change. CONCLUSIONS: Use of vapocoolant spray during NPWT dressing change for orthopedic trauma wounds and surgical incisions was feasible and resulted in significant reduction in patient-reported pain associated with the procedure. LEVEL OF EVIDENCE: Therapeutic, Level I.

Retrospective Analysis of Thromboelastography-Directed Transfusion in Isolated CABG: Impact on Blood Product Use, Cost, and Outcomes.

Cardiac surgeries account for approximately 20% of blood use in the United States. Allogeneic transfusion has been associated with increased risk of morbidity and mortality, further justifying the need to reduce blood use. This study aimed at determining whether a point-of-care coagulation test, thromboelastography (TEG), impacted blood product administration and outcomes. Patients undergoing isolated coronary artery bypass grafting (CABG) were retrospectively reviewed before the use of TEG (2008-2009) (n = 640) and after implementation (2011-2012) (n = 458). Blood product use was compared between time frames. Logistic regression and generalized linear models were created to estimate the impact on outcomes including the reoperation rate, mortality, and cost. The mean use of each blood product was significantly reduced in the perioperative period. Overall blood product use was decreased by over 40%. Mediastinal re-exploration of bleeding was significantly reduced with TEG (4.8 vs. 1.5%). Six-month mortality was not impacted in this cohort nor was the readmission rate or hospital length of stay. However, blood cost and patient charges were significantly lower after TEG was introduced. The use of TEG to guide the administration of blood products during isolated CABG significantly affected the amounts and types of products given intra- and perioperatively. This resulted in less chest tube drainage, fewer returns to the operating room, and more accurate diagnosis of coagulopathic status. Cost savings to the patient and institution were appreciated as a consequence of these improved clinical outcomes.

Thrombelastography-Directed Transfusion in Cardiac Surgery: Impact on Postoperative Outcomes.

BACKGROUND: Transfusion of allogenic blood products is associated with substantial morbidity and increased risk of mortality. Thrombelastography (TEG) to direct transfusion management during and immediately after cardiothoracic surgery reduced blood product usage in our institution. The goal of this study was to quantify the impact of TEG on postoperative outcomes. METHODS: All patients who underwent cardiac surgical procedures before and after implementation of TEG were retrospectively analyzed. Baseline patient characteristics, blood product administration, and length of stay (LOS) were compared. A logistic regression model was used to evaluate the impact of TEG on the odds of reoperation, LOS, and 6-month mortality. RESULTS: Included in analysis were 367 patients in the pre-TEG period and 310 patients in the post-TEG period. Baseline characteristics did not vary between periods. Exposure to blood products was significantly reduced after implementation of TEG (p < 0.001). The incidence of reoperation was lower in the post-TEG period (7.1% versus 3.5%, p = 0.04). Controlling for related factors on multivariate analysis, TEG was associated with reduction in postoperative LOS (11.3 versus 9.9 days, p = 0.04) and 6-month mortality (odds ratio 2.98, 95% confidence limits: 1.13 and 7.85). CONCLUSIONS: The use of TEG to guide blood product administration substantially affected patient outcomes, including LOS, odds of reoperation, and short-term mortality. The impacts appreciated may be due to the reduced use of allogenic blood products and the ability to distinguish between postoperative coagulopathy and surgical bleeding with the use of this point-of-care test.

Influencing Vaccinations: A Buzzy Approach to Ease the Discomfort of a Needle Stick-a Prospective, Randomized Controlled Trial.

BACKGROUND: The rate of annual influenza immunization in both the general public and health care workers is less than desirable. Mechanisms to improve compliance with recommendations are needed; prevention of immunization site pain has been suggested as a viable route because fear of pain and needles has been cited as a barrier. AIMS: This study aimed to evaluate the impact of thermomechanical stimulation (Buzzy) on postprocedure pain ratings during vaccination in adults. DESIGN: This was a randomized controlled trial of Buzzy during immunization. SETTINGS: Three hospitals and two community health centers which are part of a large, integrated health system. PARTICIPANTS/SUBJECTS: Employees presenting to employer-sponsored annual influenza vaccination clinics. METHODS: A 10-cm visual analog scale was used to rate preinjection anxiety and expectation of pain as well as postprocedure pain scores; participants also rated their satisfaction with the vaccine injection on a 10-point Likert scale. RESULTS: In total, 497 employee volunteers were recruited to participate. Preprocedure anxiety was similar between the experimental and control groups (1.53 vs. 1.48, p = .82), whereas self-reported postprocedure pain scores were significantly lower in the group that received the Buzzy during injection (0.87 vs. 1.12, p = .035). Mean satisfaction scores did not vary between the intervention and control groups (9.11 vs. 9.09, p = .87); however, more participants rated their experience as better than previous vaccination experiences in the Buzzy group than control (62.0% vs. 23.9%, p < .0001). CONCLUSIONS: These results suggest that Buzzy reduced pain experienced by adults undergoing annual influenza vaccination and may improve overall experience. Buzzy can be used in adult patients to reduce pain during immunization and is especially effective in those with high levels of anxiety.

Effects of Thermomechanical Stimulation During Intravenous Catheter Insertion in Adults: A Prospective Randomized Study.

This was an open-label, randomized clinical trial comparing the effects of thermomechanical stimulation (Buzzy) versus no intervention in 105 adults undergoing intravenous (IV) catheter insertion before elective orthopedic surgical procedures. A visual analog scale was used to measure pain; satisfaction questionnaires were administered after IV catheter insertion. There was no significant difference in the mean pain score between the experimental (n = 49) and control (n = 56) groups (2.52 vs 2.43, P = .86). Subjects who reported higher preprocedure anxiety benefited most from the test intervention. It was determined that the application of cold and vibration is not universally effective for pain prevention during IV catheter insertion or for improvement in patient satisfaction in preoperative care.

Effects of Thermomechanical Stimulation during Vaccination on Anxiety, Pain, and Satisfaction in Pediatric Patients: A Randomized Controlled Trial.

PURPOSE: Vaccination can be a significant source of pain for pediatric patients, which could result in fear of medical procedures and future reluctance to seek medical care. It is important for nurses to provide pain prevention during these procedures. This study sought to measure the impact of an intervention combining cold and vibration on pain scores during routine pediatric immunization. DESIGN AND METHODS: A prospective, open-label, randomized controlled trial to examine the effectiveness of the Buzzy device (thermomechanical stimulation) compared to no intervention (control group) in reducing child-reported pain during routine immunization. The Wong Baker Faces scale was used to collect child, parent, and observer reported anxiety and pain. Parents reported satisfaction with the procedure and overall office visit. RESULTS: Fifty children between the ages of 3 and 18 were included in the present analysis. Mean child-reported pain scores were significantly lower in the group receiving thermomechanical stimulation compared to control (3.56 vs 5.92, p=0.015). Buzzy did not impact child-reported anxiety or how much pain the child expected. Parent-reported satisfaction did not vary significantly between groups, but was strongly associated with parent-reported pain scores. CONCLUSIONS: Thermomechanical stimulation with the Buzzy device significantly reduced pain during pediatric immunization over a wide range of ages compared to control, but did not impact pre-procedure anxiety. PRACTICE IMPLICATIONS: The Buzzy device is an easy to implement intervention to reduce pediatric pain during vaccination. It may have the greatest impact in younger children but could be offered during all immunizations.

Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty.

BACKGROUND: The aim of this study is to determine whether negative pressure wound therapy, used prophylactically in clean surgical incisions, reduces surgical site infection, hematoma, and seroma after total joint replacement. METHODS: A single center, open-label study with a prospective cohort of patients undergoing primary total knee arthroplasty or total hip arthroplasty treated with closed incision negative pressure therapy (ciNPT) of clean surgical wounds was conducted. One hundred ninety-six incisions treated with ciNPT in 192 patients were compared with a historical control group of 400 patients treated with traditional gauze dressing. The rates of clinically significant hematoma, seroma, dehiscence, surgical site infection, and complication were compared using univariate analyses and multiple logistic regression. RESULTS: The rate of deep infection was unchanged in the ciNPT group compared with control (1.0% vs 1.25%); however, the overall rate of infection (including superficial wound infection) decreased significantly (3.5% vs 1.0%, P = .04). Overall complication rate was lower in the ciNPT group than controls (1.5% vs 5.5%, P = .02). Upon logistic regression, only treatment group was associated with complication; patients treated with ciNPT were about 4 times less likely to experience a surgical site complication compared with control (P = .0277, odds ratio 4.251, 95% confidence interval 1.172-15.414). CONCLUSION: ciNPT for total knee arthroplasty and total hip arthroplasty in a comprehensive patient population reduced overall incidence of complication, but did not significantly impact the rate of deep infection. Further research to determine clinical and economic advantages of routine use of ciNPT in total joint arthroplasty is warranted.

TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage.

Complex cardiac procedures often require blood transfusion because of surgical bleeding or coagulopathy. Thrombelastography (TEG) was introduced in our institution to direct transfusion management in cardiothoracic surgery. The goal of this study was to quantify the effect of TEG on transfusion rates peri- and postoperatively. All patients who underwent complex cardiac surgery, defined as open multiple valve repair/replacement, coronary artery bypass grafting with open valve repair/replacement, or aortic root/arch repair before and after implementation of TEG were identified and retrospectively analyzed. Minimally invasive cases were excluded. Patient characteristics and blood use were compared with t test and chi-square test. A generalized linear model including patient characteristics, preoperative and postoperative lab values, and autotransfusion volume was used to determine the impact of TEG on perioperative, postoperative, and total blood use. In total, 681 patients were identified, 370 in the pre-TEG period and 311 patients post-TEG. Patient demographics were not significantly different between periods. Mean units of red blood cells, plasma, and cryoprecipitate were significantly reduced after TEG was implemented (all, p < .0001); use of platelets was reduced but did not reach significance. Mean units of all blood products in the perioperative period and over the entire stay were reduced by approximately 40% (both, p < .0001). Total proportion of patients exposed to transfusion was significantly lower after introduction of TEG (p < .01). Controlling for related factors on multivariate analysis, such as preoperative laboratory values and autotransfusion volume, use of TEG was associated with significant reduction in perioperative and overall blood product transfusion. TEG-directed management of blood product administration during complex cardiac surgeries significantly reduced the units of blood products received perioperatively but not blood usage more than 24 hours after surgery. Overall, fewer patients were exposed to allogenic blood. The use of TEG to guide blood product administration significantly impacted transfusion therapy and associated costs.

Comparison of vein valve function following pharmacomechanical thrombolysis versus simple catheter-directed thrombolysis for iliofemoral deep vein thrombosis.

BACKGROUND: Successful catheter-directed thrombolysis (CDT) for iliofemoral deep vein thrombosis (IFDVT) reduces post-thrombotic morbidity and is a suggested treatment option by the American College of Chest Physicians for patients with IFDVT. Pharmacomechanical thrombolysis (PMT) is also suggested to shorten treatment time and reduce the dose of plasminogen activator. However, concern remains that mechanical devices might damage vein valves. The purpose of this study is to examine whether PMT adversely affects venous valve function compared to CDT alone in IFDVT patients treated with catheter-based techniques. METHODS: Sixty-nine limbs in 54 patients (39 unilateral, 15 bilateral) who underwent catheter-based treatment for IFDVT form the basis of this study. Lytic success and degree of residual obstruction were analyzed by reviewing postprocedural phlebograms. All patients underwent bilateral postprocedure duplex to evaluate patency and valve function. Phlebograms and venous duplex examinations were interpreted in a blinded fashion. Limbs were analyzed based on the method of treatment: CDT alone (n = 20), PMT using rheolytic thrombolysis (n = 14), and isolated pharmacomechanical thrombolysis (n = 35). The validated outcome measures were compared between the treatment groups. RESULTS: Sixty-nine limbs underwent CDT with or without PMT. The average patient age was 47 years (range, 16-78). Venous duplex was performed 44.4 months (mean) post-treatment. Of the limbs treated with CDT with drip technique, 65% demonstrated reflux vs 53% treated with PMT (P = .42). There was no difference in long-term valve function between patients treated with rheolytic and isolated pharmacomechanical thrombolysis. In the bilateral group, 87% (13/15) demonstrated reflux in at least one limb. In the unilateral group, 64% (25/39) had reflux in their treated limb and 36% (14/39) in their contralateral limb. There was no correlation effect of residual venous obstruction on valve function, although few patients had >50% residual obstruction. CONCLUSIONS: In patients undergoing catheter-based intervention for IFDVT, PMT does not adversely affect valve function compared with CDT alone. A higher than expected number of patients had reflux in their uninvolved limb.

A two-stage stepwise estimation procedure.

This article proposes a two-stage simultaneous confidence procedure for the comparisons of k pairs of population means, without using multiplicity adjustment of more than two populations. The proposed procedure can be broadly applied to parametric or nonparametric models. It is robust and versatile because its derivation only utilizes a partitioning approach in conjunction with a bivariate adjustment, without any assumption on the underlying distribution. To elucidate the application, the proposed procedure is intertwined with the estimation of the therapeutic window of a drug. It provides confidence limits for the efficacy and the toxicity of the effective doses, highest ineffective dose, safe doses, and lowest unsafe dose, simultaneously. Such estimation information facilitates follow-up studies in clinical trials. As an illustrative example, the new procedure is applied to analyze a data set on molecular cancer therapeutics regarding the apoptotic killing effects of different chemical compounds on two leukemia cell lines.