- Design
- Pragmatic randomised non-inferiority trial
- Population
- 201 children under 14 after open appendicectomy for perforation, Brazil
- Primary outcome
- Surgical-site infection and treatment success
- Effect
- SSI RR 0.82 (0.54–1.24); treatment success RR 1.01 (0.92–1.12)
A Brazilian randomised non-inferiority trial enrolled 201 children under 14 after open appendicectomy for perforated appendicitis. One group received metronidazole 30 mg/kg once daily, the other 10 mg/kg three times daily; both received gentamicin 5 mg/kg once daily.
Once-daily dosing was non-inferior for surgical-site infection (RR 0.82, 95% CI 0.54–1.24), organ-space infection (RR 0.82) and treatment success (RR 1.01). No severe antibiotic-related adverse events occurred. Treatment durations were similar.
Once-daily metronidazole fits well with once-daily gentamicin, freeing nursing time and simplifying ward rounds and home transition. Several centres already use it; this trial adds randomised support in children.
- Consider metronidazole 30 mg/kg once daily with once-daily gentamicin after perforated appendicitis in children
- Monitor gentamicin levels and renal function as usual
- Agree the regimen with your microbiology or antimicrobial stewardship team before changing protocol
- Note that all children in the trial had open surgery
Why it matters
A simpler antibiotic schedule saves nursing time on busy paediatric surgical wards.
The statistics, in plain English
In a non-inferiority trial the question is whether the new regimen is not meaningfully worse. Confidence intervals that run up to about 1.24 mean a modest increase in infection cannot be fully excluded with 201 children, so judgement depends on the margin the authors set.
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