Perioperative Antibiotic Use in Pediatric Surgical Patients in a Tertiary Care Hospital: A Retrospective Pharmacoepidemiological Study

Abstract

Background and Objective: Perioperative antibiotics are widely used in pediatric surgical practice; however, inappropriate selection and prolonged use may contribute to antimicrobial resistance and unnecessary exposure. Appropriate use of perioperative antibiotics is essential to prevent surgical site infections while minimizing antimicrobial resistance, adverse drug reactions, and unnecessary healthcare costs. Despite existing international recommendations, deviations from guideline-based practice remain frequent in pediatric surgical settings. This study aimed to describe patterns of perioperative antibiotic use and assess the appropriateness of prescribing practices in a tertiary care setting, and to identify factors associated with inappropriate antibiotic use. Methods: A retrospective pharmacoepidemiological study was conducted by reviewing medical records of pediatric patients admitted to a tertiary care hospital in Kosovo between January 2022 and December 2025 (data collection and record review process commencement date: 15 December 2025). A total of 650 patients aged 0–18 years who underwent surgical interventions and received perioperative antibiotics for prophylaxis or empirical treatment (defined as antibiotic therapy initiated in the presence of suspected infection) were included. Data collected comprised demographic characteristics, surgical diagnoses, type of surgery, antibiotics prescribed, weight-adjusted dosing, route of administration, timing of initiation, and duration of therapy. Appropriateness of antibiotic use was evaluated based on available documentation and compliance with WHO (2018) and CDC (2017) guidelines regarding indication, antibiotic selection, dosage, timing, and duration. Statistical analyses included descriptive statistics, chi-square tests, and multivariable logistic regression to estimate adjusted odds ratios (ORs) with 95% confidence intervals (CIs), with statistical significance set at p < 0.05. Results: Among the 650 patients, 378 (58.2%) were male and 272 (41.8%) were female, with a mean age of 6.8 ± 4.3 years. The most common types of surgery were abdominal (35.7%), otorhinolaryngological (29.4%), urological (19.1%), and orthopedic (15.8%). Perioperative antibiotics were administered predominantly for prophylaxis (91.5%), while 8.5% of patients received empirical treatment. The most frequently prescribed antibiotics were cefazolin (42.6%), ceftriaxone (34.8%), ampicillin/sulbactam (12.3%), and gentamicin (6.1%). Notably, ceftriaxone was frequently prescribed for prophylactic purposes despite international recommendations generally favoring narrow-spectrum first-line agents for perioperative prophylaxis. Intravenous administration was used in 87.9% of cases. Antibiotic duration was ≤24 h in 61.2% of patients, whereas 38.8% received antibiotics for more than 24 h. Overall, appropriate antibiotic use was identified in 62.9% of cases, while 37.1% were classified as inappropriate. Prolonged antibiotic use beyond 24 h (adjusted OR = 3.87; 95% CI: 2.68–5.58; p < 0.001) and ceftriaxone use (adjusted OR = 2.41; 95% CI: 1.63–3.55; p < 0.001), were independently associated with inappropriate antibiotic use. Conclusions: Perioperative antibiotic use in pediatric tertiary care is highly prevalent, with more than one-third of prescriptions not fully aligned with international recommendations. Prolonged antibiotic duration and the preferential use of broad-spectrum agents, particularly ceftriaxone, were the factors most strongly associated with inappropriate prescribing patterns. These findings highlight the need for improved adherence to guideline-based perioperative antibiotic protocols; however, causal inferences regarding stewardship interventions cannot be drawn from this retrospective study. The findings should be interpreted within the limitations inherent to retrospective observational studies.

1. Introduction

Perioperative antibiotics play a crucial role in modern surgical practice by reducing the risk of surgical site infections and postoperative complications, particularly in pediatric populations, where physiological vulnerability and immature immune responses may increase infection risk [1]. The appropriate use of perioperative antibiotic prophylaxis has been shown to significantly reduce the risk of surgical site infections when administered according to established guidelines regarding antibiotic selection, timing, dosage, and duration [2]. Consequently, perioperative antibiotic use represents one of the most common indications for antimicrobial exposure in hospital settings worldwide, especially in tertiary care surgical units. Ensuring adherence to standardized recommendations is therefore essential to balance infection prevention with antimicrobial safety.

Despite their proven benefits, increasing evidence indicates that antibiotics are frequently prescribed inappropriately in hospital settings, including the unnecessary use of broad-spectrum agents, incorrect timing of administration, and prolonged duration beyond recommended limits [3,4]. Such practices contribute substantially to antimicrobial overuse, which is a major driver of antimicrobial resistance (AMR) [5]. Antimicrobial resistance (AMR) is a global public health threat associated with increased mortality, prolonged hospitalization, and escalating healthcare expenditures [6,7]. In pediatric surgical care, antibiotic exposure is of particular concern, as early-life exposure to antimicrobials has been linked to long-term alterations in the microbiome and increased risk of resistant infections later in life [8]. These risks underscore the need for strict evaluation of prescribing patterns in pediatric surgical environments.

Recent global reports indicate that antimicrobial consumption continues to rise in both community and hospital settings [9,10]. Surgical departments represent an important source of antimicrobial use due to the frequent use of perioperative antibiotic prophylaxis. Moreover, antimicrobial stewardship frameworks emphasize the importance of optimizing antibiotic prescribing through appropriate selection, timing, dosing, and duration, particularly in hospital settings [11,12]. However, the translation of these stewardship principles into routine clinical practice remains inconsistent across institutions.

Although numerous studies have evaluated perioperative antibiotic use, a substantial proportion originate from high-income countries and focus predominantly on adult populations. Data from pediatric settings in low- and middle-income countries, particularly within tertiary care institutions, remain limited. Furthermore, many available studies emphasize clinical outcomes rather than adopting a pharmacoepidemiological approach. This lack of context-specific evidence hinders the development of targeted antimicrobial stewardship strategies tailored to pediatric surgical practice in resource-constrained settings. Addressing this gap is essential for informing locally applicable, evidence-based prescribing policies.

Therefore, this study aimed to describe patterns of perioperative antibiotic use and assess adherence to guideline-based prescribing practices among pediatric patients undergoing surgical interventions in a tertiary care setting. In addition, the study sought to identify factors associated with inappropriate antibiotic use using a pharmacoepidemiological approach.

2. Results

A total of 650 pediatric patients who met the predefined inclusion criteria between January 2022 and December 2025 were included in the final analysis. All patients underwent surgical procedures and received perioperative antibiotics for either prophylactic or empirical indications. The study cohort included both prophylactic and empirical antibiotic prescribing scenarios encountered in routine perioperative clinical practice. Among the 650 patients included in the study, 378 (58.2%) were male and 272 (41.8%) were female. The mean age was 6.8 ± 4.3 years.

2.1. Distribution of Surgical Procedures

Abdominal procedures were the most frequent (35.7%), followed by otorhinolaryngological (29.4%), urological (19.1%), and orthopedic surgeries (15.8%).

Table 1. Distribution of surgical procedures among pediatric patients.

Type of Surgery	n	%
Abdominal	232	35.7
Otorhinolaryngological	191	29.4
Urological	124	19.1
Orthopedic	103	15.8

presents the distribution of surgical procedures among pediatric patients.

2.2. Antibiotic Prescribing Patterns

Cefazolin was the most frequently prescribed antibiotic (42.6%), followed by ceftriaxone (34.8%), ampicillin/sulbactam (12.3%), and gentamicin (6.1%). According to the WHO AWaRe classification, ceftriaxone represented the only Watch-category antibiotic among the most frequently prescribed agents.

Table 2. Distribution of prescribed perioperative antibiotics.

Antibiotic	Pharmacological Class	n	%
Cefazolin	First-generation cephalosporin	277	42.6
Ceftriaxone	Third-generation cephalosporin	226	34.8
Ampicillin/Sulbactam	Beta-lactam/BLI	80	12.3
Gentamicin	Aminoglycoside	40	6.1
Other	–	27	4.2

presents the distribution of prescribed perioperative antibiotics.

2.3. Antibiotic Use According to Indication

Cefazolin was predominantly used for prophylaxis, whereas ceftriaxone was more frequently prescribed in empirical treatment cases. Among prophylactic prescriptions, ceftriaxone accounted for 195 cases (32.8%).

Table 3. Cross-analysis of antibiotic use according to indication (prophylaxis vs. empirical therapy).

Antibiotic	Prophylaxis n (%)	Empirical n (%)	Total
Cefazolin	270 (45.4)	7 (12.7)	277
Ceftriaxone	195 (32.8)	31 (56.4)	226
Ampicillin/Sulbactam	72 (12.1)	8 (14.5)	80
Gentamicin	36 (6.0)	4 (7.3)	40
Other	22 (3.7)	5 (9.1)	27

presents the cross-analysis of antibiotic use according to indication.

2.4. Antibiotic Distribution According to Type of Surgery

Cefazolin was most frequently used in abdominal and otorhinolaryngological procedures, whereas ceftriaxone use was relatively higher in urological surgeries. Ceftriaxone use was observed across all surgical categories.

Table 4. Distribution of prescribed antibiotics according to surgical procedure.

Type of Surgery	Cefazolin	Ceftriaxone	Ampicillin/Sulbactam	Gentamicin	Other
Abdominal	110	78	28	10	6
Otorhinolaryngological	84	61	24	12	10
Urological	48	52	15	9	0
Orthopedic	35	35	13	9	11

presents the distribution of prescribed antibiotics according to surgical procedure.

Overall, 62.9% of prescriptions were classified as appropriate, while 37.1% were considered inappropriate based on guideline criteria.

Prolonged antibiotic duration beyond 24 h was significantly associated with inappropriate prescribing (p < 0.001). Patients receiving antibiotics for more than 24 h had a higher proportion of inappropriate use (63.1%) compared to those treated for ≤24 h (20.6%).

Multivariable analysis showed that antibiotic duration >24 h (adjusted OR = 3.87; 95% CI: 2.68–5.58; p < 0.001) and use of ceftriaxone (adjusted OR = 2.41; 95% CI: 1.63–3.55; p < 0.001) were independently associated with inappropriate prescribing. Reference categories: antibiotic duration ≤24 h; non-ceftriaxone antibiotic use.

3. Discussion

This retrospective pharmacoepidemiological study provides an evaluation of perioperative antibiotic prescribing practices among pediatric surgical patients in a tertiary care setting. The findings demonstrate that a considerable proportion of antibiotic prescriptions were not aligned with international guideline recommendations, with 37.1% classified as inappropriate. The analysis further identified prolonged antibiotic duration and the use of broad-spectrum agents, particularly ceftriaxone, as the main factors associated with inappropriate prescribing. According to the WHO AWaRe classification, ceftriaxone represented the only Watch-category antibiotic among the most frequently prescribed agents in the study cohort. Notably, ceftriaxone was also commonly prescribed for prophylactic purposes, accounting for 195 prophylactic prescriptions, despite current international recommendations generally favoring narrow-spectrum first-generation cephalosporins for most pediatric surgical procedures. These findings should be interpreted as associations rather than causal relationships, given the retrospective design of the study. It should also be noted that empirical therapy cases may represent clinically justified deviations from prophylactic recommendations, particularly in the presence of suspected infection, where broader-spectrum antibiotics and longer duration of therapy may be appropriate. Therefore, part of the observed inappropriate use may reflect limitations in available clinical detail rather than true non-compliance. The combined analysis of prophylactic and empirical antibiotic use may also introduce a degree of systematic bias in the interpretation of prescribing appropriateness, as empirical therapy is commonly influenced by suspected infection severity, intraoperative findings, and clinical judgment that were not fully captured in the retrospective records.

The predominance of perioperative antibiotic prophylaxis observed in this study is consistent with global surgical practice, where prophylactic antimicrobial administration represents a key strategy for preventing surgical site infections [1,2]. However, our results indicate that antibiotic exposure frequently exceeded recommended durations. A substantial proportion of patients received antibiotics for more than 24 h, which is not supported by most international guidelines. Similar findings have been reported in previous studies, suggesting that prolonged prophylaxis remains a widespread issue across different healthcare systems [3,4]. Prolonged antibiotic use has been associated with increased antimicrobial resistance, unnecessary healthcare costs, and avoidable adverse drug effects, without additional clinical benefit in preventing postoperative infections [5]. In the present cohort, prolonged antibiotic administration beyond 24 h was frequently observed among patients receiving ceftriaxone, further emphasizing the importance of antimicrobial stewardship interventions targeting both antibiotic spectrum and duration of therapy.

Another important finding is the frequent use of third-generation cephalosporins, particularly ceftriaxone. The availability and implementation of local perioperative antibiotic guidelines within the study setting were not formally assessed, which may have contributed to variability in prescribing practices. Antimicrobial stewardship is particularly important in high-risk clinical settings, such as intensive care units, where inappropriate antibiotic use may contribute to adverse outcomes [13]. Current guidelines recommend narrow-spectrum agents, such as cefazolin, for the majority of pediatric surgical procedures [1,2]. Despite this, broader-spectrum antibiotics were commonly prescribed in the present cohort. The relatively high use of ceftriaxone across prophylactic prescribing scenarios is clinically relevant because ceftriaxone belongs to the WHO Watch group of antibiotics, which should generally be reserved for specific clinical indications due to their broader resistance selection potential. This pattern is consistent with studies conducted in similar settings, where prescribing behavior may be influenced by perceived infection risk, clinical uncertainty, or lack of local antimicrobial stewardship protocols. In the present study, the absence of consistently documented surgical wound classification limited the ability to fully differentiate cases where broader-spectrum therapy may have been clinically justified, particularly in potentially contaminated or dirty surgical procedures. The high use of ceftriaxone across different surgical categories suggests potential deviation from guideline-recommended first-line therapy, particularly in procedures where narrow-spectrum prophylaxis would be sufficient. Furthermore, ceftriaxone use was observed across multiple surgical categories, including abdominal, otorhinolaryngological, urological, and orthopedic procedures, suggesting that broad-spectrum perioperative coverage may have extended beyond situations where it would typically be recommended according to international prophylaxis guidelines.

The multivariable analysis identified prolonged antibiotic duration and ceftriaxone use as independent factors associated with inappropriate prescribing. Patients receiving antibiotics for more than 24 h had a significantly higher likelihood of inappropriate use, and ceftriaxone use was associated with increased odds of non-compliance with guidelines. The regression model demonstrated acceptable statistical stability and goodness-of-fit, supporting the robustness of the observed associations despite the retrospective nature of the dataset. These findings are consistent with previous research highlighting duration and antibiotic spectrum as key determinants of prescribing quality in surgical settings. However, these associations should be interpreted with caution, as some patients particularly those receiving empirical therapy may have had clinical indications requiring prolonged treatment or broader-spectrum coverage.

The analysis of antibiotic use according to indication further supports this interpretation. Cefazolin was predominantly used for prophylaxis, whereas ceftriaxone was more frequently prescribed in empirical treatment scenarios. However, a substantial proportion of ceftriaxone prescriptions were also related to prophylactic use, indicating that broad-spectrum perioperative prescribing was not limited exclusively to empirical treatment scenarios. This distinction is clinically relevant, as empirical therapy is often initiated in the context of suspected infection and may justify broader-spectrum coverage and longer duration compared to prophylaxis. Therefore, part of the observed “inappropriate” use may reflect limitations in the available clinical data rather than true deviations from best practice.

An important methodological consideration in this study is the absence of consistent surgical wound classification (clean, clean-contaminated, contaminated, or dirty) in the available medical records. This represents a key methodological constraint, as wound classification directly determines both the indication and spectrum of perioperative antibiotics. The lack of this information may have influenced the classification of appropriateness, particularly in cases where broader-spectrum agents or prolonged duration may have been clinically justified. Similarly, incomplete documentation regarding the exact timing of antibiotic administration relative to surgical incision may have affected the evaluation of compliance with perioperative prophylaxis standards in a subset of patients. Nevertheless, the evaluation of antibiotic appropriateness was based on established guideline criteria related to antibiotic selection, timing, dosing, and duration, which remain broadly applicable across pediatric surgical interventions.

This study contributes to the limited body of evidence on perioperative antibiotic use in pediatric populations, particularly in low- and middle-income countries. Most existing studies on perioperative antibiotic use have been conducted in adult populations or high-income settings, which may limit their applicability to pediatric surgical practice in resource-constrained environments. By providing data from a tertiary care center in Kosovo, this study adds context-specific evidence that may inform the development of locally adapted antimicrobial stewardship strategies. The tertiary care status of the institution is particularly relevant when interpreting these findings, as referral hospitals frequently manage more complex pediatric surgical cases that may require individualized antimicrobial decision-making beyond standard prophylactic protocols.

Several limitations should be considered when interpreting these findings. The retrospective design relies on the accuracy and completeness of medical records, and certain clinically relevant variables may not have been consistently documented. Additionally, economic factors such as drug availability and cost may influence antibiotic selection in clinical practice, although this aspect was not evaluated in the present study. The study was conducted in a single tertiary care institution, which may limit the generalizability of the results. In addition, the combined evaluation of prophylactic and empirical antibiotic prescribing may have introduced classification bias, since some empirical therapy cases could represent clinically justified deviations from standard prophylactic recommendations. In addition, microbiological data and postoperative infection outcomes were not systematically available. In addition, subgroup analyses according to ceftriaxone duration and surgical risk classification could not be comprehensively performed because of incomplete retrospective documentation. Furthermore, incomplete documentation of timing of antibiotic administration and lack of detailed stratification by surgical risk categories may have affected the assessment of appropriateness. Furthermore, the absence of standardized wound classification data limited the ability to fully stratify prescribing appropriateness according to surgical risk categories and perioperative prophylaxis quality indicators. These limitations should be taken into account when interpreting the results.

Despite these limitations, the relatively large sample size and extended study period strengthen the reliability of the findings. The study provides a comprehensive overview of antibiotic prescribing patterns in pediatric surgical care and identifies key areas where practice may be improved. Future studies should incorporate prospective designs, standardized data collection, and inclusion of microbiological and surgical risk classification data to allow more precise evaluation of antibiotic appropriateness.

4. Materials and Methods

4.1. Study Design and Setting

This study was designed as a retrospective pharmacoepidemiological analysis conducted in the Department of Pediatrics at the General Hospital in Gjilan, Kosovo, a tertiary care healthcare institution. Medical records of pediatric patients admitted between January 2022 and December 2025 (data collection and record review process commencement date: 15 December 2025) were reviewed to describe patterns of perioperative antibiotic use and assess prescribing appropriateness in pediatric surgical care. The General Hospital in Gjilan is a public regional referral hospital that provides secondary and selected tertiary pediatric surgical services for the southeastern region of Kosovo. The institution manages a heterogeneous spectrum of pediatric surgical procedures, including abdominal, otorhinolaryngological, urological, and orthopedic interventions, and receives referrals from surrounding primary and secondary healthcare facilities. This organizational structure supports its role as a tertiary care setting for the purposes of pharmacoepidemiological evaluation of perioperative antibiotic prescribing practices.

4.2. Study Population

The study included pediatric patients aged 0–18 years who were hospitalized, underwent surgical interventions, and received perioperative antibiotics for prophylactic or empirical treatment (defined as antibiotic therapy initiated in the presence of suspected or confirmed infection rather than for prophylaxis). A total of 650 patients met the inclusion criteria and were included in the final analysis.

The age range was defined according to WHO classification standards for pediatric populations. A structured screening process was applied to eligible medical records to ensure completeness and consistency of data extraction.

Patients were excluded if medical records were incomplete, if hospitalization lasted less than 24 h without antibiotic administration, or if patients were transferred from other institutions without complete perioperative documentation.

4.3. Data Collection

Data were retrospectively extracted using a standardized data collection form. Collected variables included demographic characteristics (age, sex, body weight), clinical and surgical data (primary diagnosis, type of surgery, urgency of procedure [elective vs. emergency]), and pharmacological data related to antibiotic use.

Antibiotic-related variables included antibiotic class, indication (prophylaxis or empirical treatment), weight-adjusted dosage, route of administration, timing of initiation relative to surgery, and duration of therapy. All extracted data were reviewed for internal consistency prior to analysis.

4.4. Assessment of Antibiotic

The appropriateness of perioperative antibiotic use was evaluated based on compliance with WHO (2018) and CDC (2017) guidelines. Prescribing was considered appropriate if it fulfilled the following criteria based on available clinical documentation: appropriate indication, selection of recommended first-line agents, documented weight-adjusted dosing where sufficient information was available, administration within the recommended preoperative time window, and duration not exceeding 24 h for prophylaxis unless clinically justified.

Any deviation from these criteria, including the use of broad-spectrum antibiotics without clear indication or prolonged prophylaxis beyond 24 h, was classified as inappropriate use.

Due to the retrospective design of the study, formal surgical wound classification (clean, clean-contaminated, contaminated, and dirty) was not consistently documented in the medical records and therefore was not included in the analytical framework.

Similarly, although the timing of antibiotic administration relative to surgical incision was initially collected during data extraction, incomplete documentation in a subset of records limited its inclusion in the final analytical models.

Prophylactic and empirical antibiotic use were analyzed within the same study cohort because both prescribing approaches were routinely documented in perioperative clinical practice during the study period.

Dosage assessment was based on weight-adjusted prescribing as documented in medical records. However, due to the retrospective nature of the study, detailed verification of dosing accuracy relative to guideline-recommended ranges was limited.

4.5. Outcome Measures

The primary outcome was the proportion of appropriate versus inappropriate perioperative antibiotic use. Secondary outcomes included identification of factors associated with inappropriate prescribing, including type of surgery, antibiotic class, and duration of therapy.

4.6. Statistical Analysis

Statistical analysis was performed using SPSS software version 31 (IBM Corp., Armonk, NY, USA). Descriptive statistics were used to summarize patient characteristics and perioperative antibiotic prescribing patterns. Associations between categorical variables were assessed using the chi-square test.

Multivariable logistic regression analysis was conducted to identify independent factors associated with inappropriate antibiotic use. Variables initially considered for inclusion in the regression model were selected based on clinical relevance, previous literature, and availability within the retrospective dataset. These variables included age, sex, type of surgery, urgency of procedure (elective versus emergency), antibiotic class, route of administration, and duration of therapy.

Variables demonstrating potential association in univariable analyses and variables considered clinically relevant were entered into the multivariable logistic regression model using a stepwise selection approach to derive the final adjusted model. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated.

Model calibration was assessed using the Hosmer–Lemeshow goodness-of-fit test, while multicollinearity between independent variables was evaluated using variance inflation factor (VIF) values. No significant multicollinearity was identified among variables included in the final model. A p-value < 0.05 was considered statistically significant. The study is reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for observational studies.

4.7. Ethical Considerations

The study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the hospital ethics committee. Given the retrospective design and anonymized data, the requirement for informed consent was waived.

5. Conclusions

This pharmacoepidemiological study demonstrated that a substantial proportion of perioperative antibiotic prescriptions in pediatric tertiary care were not fully aligned with international guideline recommendations. Prolonged antibiotic duration and preferential use of broad-spectrum agents, particularly ceftriaxone, were the factors most strongly associated with inappropriate prescribing patterns. These findings support the need for improved adherence to guideline-based perioperative antibiotic practices and strengthened antimicrobial stewardship strategies in pediatric surgical care.

Limitations: The retrospective single-center design relied on the completeness of medical records, and several clinically relevant variables, including surgical wound classification and timing of antibiotic administration, were incompletely documented. In addition, microbiological data and postoperative infection outcomes were not systematically available, and the combined evaluation of prophylactic and empirical antibiotic use may have introduced classification bias in selected cases. Despite these limitations, the large sample size and extended study period provide a comprehensive overview of perioperative antibiotic prescribing patterns in pediatric tertiary care.