IMPORTANCEThe opioid epidemic has generated interest in optimizing opioid prescribing after common surgeries. Recent studies have shown a broad range of analgesic prescription patterns following endoscopic sinus surgery (ESS).OBJECTIVE To compare the efficacy of different analgesic regimens after ESS. DESIGN, SETTING, AND PARTICIPANTSThis multi-institutional, nonblinded randomized clinical trial was conducted at 6 tertiary centers across the US and Canada and included participants who underwent ESS for acute or chronic rhinosinusitis. The study was conducted from March 2019 to March 2020, and the data were analyzed in November to December 2020.INTERVENTIONS All participants received acetaminophen, 650 mg, as the first-line analgesic. From there, patients were randomized to either oxycodone rescue (oxycodone, 5 mg, as second-line therapy) or ibuprofen rescue (ibuprofen, 600 mg, as second-line therapy, with oxycodone, 5 mg, reserved for breakthrough pain).MAIN OUTCOMES AND MEASURES Baseline characteristics and disease severity were collected at enrollment. Medication logs, pain scores, and epistaxis measures were collected until postoperative day 7. The primary outcome was the postoperative visual analog scale score for pain. Brief Pain Inventory Pain Severity and Pain Interference Scores were also collected. RESULTS A total of 118 patients were randomized (62 [52.5%] oxycodone rescue, 56 [47.5%] ibuprofen rescue; mean [SD] age, 46.7 [16.3] years; 44 women [44.0%]; 83 White [83.0%], 7 Black [7.0%], and 7 Asian individuals [7.0%]). After exclusions for loss to follow-up and noncompliance, 51 remained in the oxycodone rescue group and 49 in the ibuprofen rescue group. The groups had similar demographic characteristics and disease severity. Thirty-two (63%) in the oxycodone rescue group had adequate pain management with acetaminophen only, while 19 (37%) consumed at least 1 oxycodone dose. In the ibuprofen rescue group, 18 (16%) required only acetaminophen, 28 (57%) used only acetaminophen and ibuprofen, and the remaining 13 (26%) consumed 1 or more oxycodone doses. The groups had similar average acetaminophen (9.69 vs 7.96 doses; difference, 1.73; 95% CI, -1.37 to 4.83) and oxycodone (1.89 vs 0.77 doses; difference, 1.13; 95% CI, -0.11 to 2.36) use. Both groups had similar postoperative visual analog scale scores. A subanalysis that compared opioids users with nonusers showed clinically significant lower pain scores in nonusers at multiple postoperative points. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, most patients who underwent ESS could be treated postoperatively using a nonopioid regimen of either acetaminophen alone or acetaminophen and ibuprofen. Ibuprofen as a second-line therapy did not reduce overall narcotic consumption, but the overall narcotic use was low in both groups.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03783702
Objectives Our objectives were (1) to use in situ simulation to assess the clinical environment and identify latent safety threats (LSTs) related to the management of pediatric tracheostomy patients and (2) to analyze the effects of systems interventions and team factors on LSTs and simulation performance. Methods A multicenter, prospective study to assess LSTs related to pediatric tracheostomy care management was conducted in emergency departments (EDs) and intensive care units (ICUs). LSTs were identified through equipment checklists and in situ simulations via structured debriefs and blinded ratings of team performance. The research team and unit champions developed action plans with interventions to address each LST. Reassessment by equipment checklists and in situ simulations was repeated after 6 to 9 months. Results Forty-one LSTs were identified over 21 simulations, 24 in the preintervention group and 17 in the postintervention group. These included LSTs in access to equipment (ie, availability of suction catheters, lack of awareness of the location of tracheostomy tubes) and clinical knowledge gaps. Mean equipment checklist scores improved from 76% to 87%. Twenty-one unique teams (65 participants) participated in the simulations. The average simulation score was 6.19 out of 16 points. Discussion In situ simulation is feasible and effective as an assessment tool to identify latent safety threats and thus measure the system-level performance of a clinical care environment. Implications for Practice In situ simulation can be used to identify and reassess latent safety threats related to pediatric tracheostomy management and thereby support quality improvement and educational initiatives.
Background Aspirin desensitization and treatment benefits most patients with aspirin‐exacerbated respiratory disease (AERD), although some patients fail therapy. Our objective was to assess whether recent endoscopic sinus surgery (ESS) improved aspirin treatment outcomes in AERD patients who initially failed aspirin therapy. Methods Outcomes of aspirin desensitization and treatment in AERD patients prospectively enrolled were assessed preoperatively and at 4, 12, and 24 weeks after ESS by determining changes in Asthma Control Test (ACT) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores and respiratory function. Biomarkers, including fractional excretion of nitric oxide (FeNO), spirometry, nasal inspiratory peak flow (NPF), immunoglobulin E (IgE), and eosinophil count, were measured. Results Nineteen patients who benefited (responders) and 21 patients who failed (nonresponders) preoperative aspirin treatment with a distant history of ESS (mean, 48 months) were identified. Nonresponders were more likely to be African American (71%, p < 0.01) and have higher baseline IgE levels (252 kU/L vs 87 kU/L in responders, p < 0.01). 24 of the 40 patients (nine responders and 15 non‐responders) required subsequent ESS and underwent another aspirin desensitization 3‐4 weeks after ESS. All 24 patients tolerated a second round of aspirin desensitization and treatment. The primary aspirin therapy was associated with a significant increase in IgE in nonresponders, but there was no significant increase in IgE after the second aspirin desensitization and treatment. Conclusion Antecedent ESS enhances aspirin treatment responses in AERD patients and may convert patients who failed aspirin treatment before surgery to a more responsive phenotype after ESS. Patients with higher baseline serum IgE levels may benefit from ESS performed shortly before aspirin desensitization and therapy.
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