Randomized controlled trial of NSAID prior to cystoscopic ureteral stent removal in a pediatric population.

INTRODUCTION: Ureteral spasm, common with ureteral stents, is partially mediated by prostaglandins and may be suppressed by cyclooxygenase inhibitors like non-steroidal anti-inflammatory (NSAIDs). Practices currently vary widely for pain management in patients with ureteral stents, sometimes including opioids. OBJECTIVE: We aimed to determine if NSAID given prior to stent removal would reduce postoperative pain. We hypothesized there would be at least a 75% reduction in postoperative severe pain (pain score ≥7) in patients receiving ibuprofen compared to placebo. STUDY DESIGN: We performed a double-blind, placebo-controlled randomized controlled trial on pediatric urology patients with an indwelling ureteral stent undergoing removal in the operating room from 2014 to 2019. 20 patients in each arm were needed to achieve 80% power to detect a 75% reduction in the estimated 55% incidence of severe postoperative pain (α = 0.05). Patients ≥4 years old who had a unilateral stent placed after treatment of urolithiasis or ureteropelvic junction obstruction were randomized to NSAID or placebo in a 1:1 ratio at least 15 min prior to scheduled stent removal. Patients estimated pain using Faces Pain Scale-Revised (FPS-R) or visual analogue scale (VAS) prior to and 24 h after stent removal. RESULTS: 254 patients undergoing stent removal were assessed for eligibility, and 44 randomized patients were analyzed using intention to treat analysis. The cohorts were demographically similar and received similar anesthesia treatment. There was no significant difference in maximum post anesthesia care unit pain score (p = 0.269) or use of in-hospital opioids (p = 0.626) between the two groups. No difference was seen in the incidence of severe postoperative pain (p = 1.0), thus rejecting the hypothesis. Significant worsened postoperative pain (pain score increases of ≥2 between time points) decreased from 22.7% to 13.6% between placebo and NSAID, but this did not reach significance (p = 0.410). DISCUSSION: There was no difference in postoperative pain for patients undergoing ureteral stent removal given preoperative NSAID versus placebo. The incidence of severe pain before and after stent removal was low, ranging from 4.5 to 9.1%. CONCLUSION: Research to understand the etiology of pain after stent removal and techniques to minimize or prevent discomfort should continue in order to optimize patient outcomes.

Use of Surgical Risk Preoperative Assessment System (SURPAS) and Patient Satisfaction During Informed Consent for Surgery.

BACKGROUND: The objective of this study was to determine the effects of using the Surgical Risk Preoperative Assessment System (SURPAS) on patient satisfaction and surgeon efficiency in the surgical informed consent process, as compared to surgeons' "usual" consent process. STUDY DESIGN: Patient perception of the consent process was assessed via survey in 2 cohorts: 10 surgeons in different specialties used their "usual" consent process for 10 patients; these surgeons were then taught to use SURPAS, and they used it during the informed consent process of 10 additional patients. The data were compared using Fisher's exact test and the Cochran-Mantel-Haenszel test. RESULTS: One hundred patients underwent the "usual" consent process (USUAL), and 93 underwent SURPAS-guided consent (SURPAS). Eighty-two percent of SURPAS were "very satisfied" and 18% were "satisfied" with risk discussion vs 16% and 72% of USUAL, respectively. Of those who used SURPAS, 75.3% reported the risk discussion made them "more comfortable" with surgery vs 19% of USUAL, and 90.3% of SURPAS users reported "somewhat" or "greatly decreased" anxiety vs 20% of USUAL. All p values were <0.0001. Among SURPAS patients, 97.9% reported "enough time spent discussing risks" vs 72.0% of USUAL patients. CONCLUSIONS: The SURPAS tool improved the informed consent process for patients compared with the "usual" consent process, in terms of patient satisfaction, ie making patients feel more comfortable and less anxious about their impending operations. Providers should consider integrating the SURPAS tool into their preoperative consent process.

Systematic Review of Preoperative Risk Discussion in Practice.

BACKGROUND: Informed consent is an ethical imperative of surgical practice. This requires effective communication of procedural risks to patients and is learned during residency. No systematic review has yet examined current risk disclosure. This systematic review aims to use existing published information to assess preoperative provision of risk information by surgeons. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses as a guide, a standardized search in Ovid MEDLINE, Embase, CINHAL, and PubMed was performed. Three reviewers performed the study screening, with 2-reviewer consensus required at each stage. Studies containing objective information concerning preoperative risk provision in adult surgical patients were selected for inclusion. Studies exclusively addressing interventions for pediatric patients or trauma were excluded, as were studies addressing risks of anesthesia. RESULTS: The initial search returned 12,988 papers after deduplication, 33 of which met inclusion criteria. These studies primarily evaluated consent through surveys of providers, record reviews and consent recordings. The most ubiquitous finding of all study types was high levels of intra-surgeon variation in what risk information is provided to patients preoperatively. Studies recording consents found the lowest rates of risk disclosure. Studies using multiple forms of investigation corroborated this, finding disparity between verbally provided information vs chart documentation. CONCLUSIONS: The wide variance in what information is provided to patients preoperatively inhibits the realization of the ethical and practical components of informed consent. The findings of this review indicate that significant opportunities exist for practice improvement. Future development of surgical communication tools and techniques should emphasize standardizing what risks are shared with patients.

ABO Genotype and Blood Type Are Associated with Otitis Media.

Aim: To determine if there is an association between ABO variants or blood types and otitis media. Methods: DNA samples from 214 probands from Finnish families with recurrent acute (RAOM) and/or chronic otitis media with effusion (COME) were submitted for exome sequencing. Fisher exact tests were performed when (a) comparing frequencies of ABO genotypes in the Finnish probands with otitis media vs. counts in gnomAD Finnish, and (b) within the Finnish family cohort, comparing occurrence of RAOM vs. COME according to ABO genotype/haplotype and predicted blood type. Results: Female sex is protective against having both RAOM and COME. The wildtype genotype for the ABO c.260insG (p.Val87_Thr88fs*) variant resulting in blood type O was protective against RAOM. On the other hand, type A was associated with increased risk for COME. These findings remained significant after adjustment for age and sex. Conclusions: Within the Finnish family cohort, the wildtype genotype for the ABO c.260insG (p.Val87_Thr88fs*) variant and type O are protective against RAOM while type A increases risk for COME. This suggests that the association between the ABO locus and otitis media is specific to blood type, otitis media type and cohort.