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Single-Dose Antibiotic Prophylaxis Compared With Multiple-Dose Protocol in Clean Pediatric Neurosurgical Interventions: A Nonrandomized, Historically Controlled Equivalence Trial Publisher Pubmed



Mohammadi E1 ; Azadnajafabad S1, 2 ; Goudarzi M3 ; Tayebi Meybodi K1 ; Nejat F1 ; Habibi Z1
Authors
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Authors Affiliations
  1. 1. Department of Pediatric Neurosurgery, Children’s Medical Center Hospital, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Pediatric Anesthesiology, Children’s Medical Center Hospital, Tehran University of Medical Sciences, Tehran, Iran

Source: Journal of Neurosurgery: Pediatrics Published:2022


Abstract

OBJECTIVE Guidelines recommend antimicrobial prophylaxis (AMP) preoperatively for “clean” spinal and cranial surgeries, while dose and timing remain controversial. The use of multiple-dose AMP for such surgeries is under debate in the pediatric context. In this clinical study, the authors aimed to compare single-dose with multiple-dose prophylactic antibiotic usage in cranial and spinal neurosurgical interventions of pediatric patients. METHODS All neurosurgical patients aged 28 days to 18 years who underwent surgery at a single tertiary center were assessed. Three cohorts (noninstrumented clean spinal, noninstrumented cranial, and instrumented cranial interventions), each of which comprised two 50-patient arms (i.e., single-dose AMP and multiple-dose AMP), were included after propensity score–matched retrospective sampling and power analysis. Records were examined for surgical site infections. Using a previously published meta-analysis as the prior and 80% acceptance of equivalence (margin of OR 0.88–1.13), logistic regression was carried out for the total cohort and each subcohort and adjusted for etiology by consideration of multiple-dose AMP as reference. RESULTS The overall sample included 300 age- and sex-matched patients who were evenly distributed in 3 bi-arm cohorts. There was no statistical intercohort difference based on etiology or type of operation (p < 0.05). Equivalence analysis revealed nondiscriminating results for the total cohort (adjusted OR 0.65, 95% CI 0.27–1.57) and each of the subcohorts (noninstrumented clean spinal, adjusted OR 0.65, 95% CI 0.12–3.44; noninstrumented cranial, adjusted OR 0.52, 95% CI 0.14–2.73; and instrumented cranial, adjusted OR 0.68, 95% CI 0.13–3.31). CONCLUSIONS No significant benefit for multiple-dose compared with single-dose AMPs in any of the pediatric neurosurgery settings could be detected. Since unnecessary antibiotic use should be avoided as much as possible, it seems that usage of single-dose AMP is indicated. © AANS 2022, except where prohibited by US copyright law.