Pediatrics · Surgery · 3 h ago
Once-Daily Metronidazole Non-Inferior in Children With Perforated Appendicitis
A real-world randomized non-inferiority trial in 201 children younger than 14 compared once-daily with three-times-daily metronidazole, with gentamicin in both regimens, after open appendectomy for perforated appendicitis. Surgical-site infection and treatment success results met the study’s non-inferiority criteria; no severe antibiotic-related adverse events were recorded.
- Randomized trial included 201 children with perforated appendicitis.
- Both regimens included once-daily gentamicin.
- Once-daily metronidazole met non-inferiority criteria for reported outcomes.
- No severe antibiotic-related adverse events were recorded.
This real-world randomized non-inferiority trial enrolled 201 children younger than 14 years who underwent open appendectomy for perforated appendicitis between 2022 and 2023. The intervention group (n=99) received metronidazole 30 mg/kg once daily; the control group (n=102) received 10 mg/kg three times daily. Both groups also received gentamicin 5 mg/kg once daily. Outcomes included surgical-site infection (SSI), SSI by location, treatment success, adverse events and antibiotic costs.
The once-daily regimen met non-inferiority criteria for SSI (risk ratio [RR] 0.82; 95% CI 0.54–1.24), incisional SSI (RR 0.81; 95% CI 0.55–1.19), organ/space SSI (RR 0.82; 95% CI 0.56–1.19) and treatment success (RR 1.01; 95% CI 0.92–1.12). No severe antibiotic-related adverse events were recorded. Median metronidazole treatment duration was six days versus 5.5 days, and the once-daily group had a mean metronidazole cost reduction of US$1.71 per patient.
The findings support the simplified schedule as a potential alternative in this study setting. Applicability may be limited because all participants had open surgery; the abstract does not report the non-inferiority margin or setting details. The trial was registered as RBR-95gbvmq.
In practice
For children younger than 14 years treated with open appendectomy for perforated appendicitis, this randomized trial found once-daily metronidazole combined with once-daily gentamicin non-inferior to three-times-daily metronidazole with the same gentamicin regimen for SSI and treatment success. No severe antibiotic-related adverse events were reported. These findings suggest the simplified schedule may be an option in a similar setting, but they do not establish applicability to laparoscopic surgery or other populations; the supplied abstract does not state the non-inferiority margin or study setting.
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World Journal of Surgery: A Single Daily Dose of Metronidazole is Non‐Inferior to Three Daily Doses in Children With Perforated Appendicitis: A Real‐World Randomized Trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.