title: Adverse events associated with surgical antibiotic prophylaxis for outpatient circumcisions at US children's hospitals.
abstract: BACKGROUND
  Doctors often use surgical antibiotic prophylaxis (SAP) despite limited evidence to support its efficacy. We sought to determine the association between SAP in children undergoing circumcision and the rate of perioperative adverse events.
  
  
  METHODS
  We performed a retrospective study of males >30 days old and <18 years old who underwent circumcision from 2004 to 2014 using the Pediatric Health Information System database. We excluded inpatients and those with any concomitant procedures. We used chi-square or Fisher's exact test to determine the association between SAP and allergic reaction and any of the following within 30 days: penile reoperation, hospital visit, or surgical site infection (SSI). We performed mixed effects logistic regression controlling for age, race, insurance, and clustering of similar practice patterns by hospital.
  
  
  RESULTS
  84,226 patients were included: median age 2.2 years; 61.0% public insurance, 39.6% white. 8944 (10.6%) received SAP. On bivariate analysis, there were no associations between SAP and SSI (0.1% vs. 0.2%, p = 0.5), penile reoperation (0.01% vs. 0.04%, p = 0.4), or hospital visit (5.5% vs. 5.5%, p = 0.8). Patients who received SAP were more likely to have a perioperative allergic reaction than those who did not (3.5% vs. 2.9%, p = 0.0004). On multivariate analysis, those who received SAP had 1.5 times the odds of an allergic reaction (OR 1.5, 95% CI 1.3-1.7; p < 0.0001) and a hospital visit (OR 1.2, 95% CI 1.1-1.3; p = 0.0021) compared with those who did not (Table).
  
  
  CONCLUSIONS
  SAP did not decrease the risk of penile reoperation or SSI. Use of SAP was associated with an increased risk of allergic reactions and hospital visits. Strengths of the study include its large sample size, which enabled detection of rare outcomes with adequate statistical power and the generalizability of our findings to many patients and other types of procedures. Limitations include the lack of outpatient data and the possibility that we could have overestimated the incidence of allergic reactions by including patients who received epinephrine for some other reason.
  
  
  CONCLUSIONS
  We found no compelling evidence to support the use of SAP in children undergoing circumcision and it was associated with an increased risk of allergic reaction and hospital visits. This study highlights the need for specialty-specific guidelines for pediatric urologic procedures regarding the use of antibiotics for prophylaxis and for vigilant monitoring of practice variation.
authors.affiliation: Division of Pediatric Urology, Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA; Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: kchubert@iupui.edu.
authors.forename: Katherine H
authors.initials: KH
authors.lastname: Chan
authors.affiliation: Division of Pediatric Urology, Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA; Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Whittam
authors.affiliation: Department of Biostatistics, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis, IN, USA.
authors.forename: Elizabeth A S
authors.initials: EAS
authors.lastname: Moser
authors.affiliation: Division of Pediatric Urology, Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Mark P
authors.initials: MP
authors.lastname: Cain
authors.affiliation: Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: William E
authors.initials: WE
authors.lastname: Bennett
mesh_terms: D017677:Age Distribution; D000704:Analysis of Variance; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D002944:Circumcision, Male / Q000009:adverse effects* / Q000379:methods; D015331:Cohort Studies; D016208:Databases, Factual; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000503:physiopathology / Q000517:prevention & control; D012189:Retrospective Studies; D018570:Risk Assessment; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000517:prevention & control*; D014481:United States
keywords: Anti-bacterial agents; Circumcision; Drug-related side effects and adverse reactions; Perioperative care