Assessing the Longitudinal outcomes of Piperacillin/tazobactam versus ceftriAxone and metronidazole for Children with
Daniel Briatico1,2, Nadia Safa1,2, Helene Flageole1,2
1Division of Pediatric Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Insights
This pilot study will assess the feasibility of comparing two antibiotic regimens for children with perforated appendicitis. It aims to inform a larger trial on optimal postoperative antibiotic therapy.
Area of Science:
- Pediatric Surgery
- Infectious Diseases
- Clinical Trial Design
Background:
- Acute appendicitis is a common surgical emergency in children.
- Perforated appendicitis often requires postoperative antibiotics, but treatment effectiveness varies.
- Optimal antibiotic regimens for perforated appendicitis in children are not well-established.
Purpose of the Study:
- To evaluate the feasibility of a blinded randomized controlled trial comparing two antibiotic strategies for perforated appendicitis in children.
- To inform the design of a larger, multicenter study for definitive outcome assessment.
Main Methods:
- A double-blind, randomized controlled pilot trial involving children under 18 undergoing laparoscopic appendectomy for perforated appendicitis.
- Comparison of two antibiotic regimens: piperacillin/tazobactam versus ceftriaxone and metronidazole.
- Pilot study sample size of 16 participants (8 per group), assessing feasibility outcomes like recruitment and adherence.
Main Results:
- This section is not applicable for a pilot feasibility study as primary results focus on feasibility metrics.
- Feasibility outcomes include recruitment rate, protocol adherence, loss to follow-up, and cost per participant.
Conclusions:
- This pilot study will determine the feasibility of a rigorous, blinded randomized controlled trial for pediatric perforated appendicitis.
- Findings will guide a larger study to compare piperacillin/tazobactam with ceftriaxone/metronidazole for superior outcomes.
Background:
Acute appendicitis is the most common indication for emergency surgery in children. In cases of perforation, patients require post-operative intravenous antibiotics in hospital. However, some children fail to respond adequately, resulting in prolonged hospitalization. The optimal antibiotic regimen for perforated appendicitis remains uncertain.
Methods:
We propose a double-blind, randomized controlled pilot trial comparing two commonly used antibiotic strategies. Eligible participants include children <18 years undergoing laparoscopic appendectomy for perforated appendicitis. Following surgery, participants will be randomized to receive either: (1) piperacillin/tazobactam; or (2) ceftriaxone and metronidazole. The sample size for the pilot study is 16 participants (i.e., 8 per group). Feasibility outcomes include recruitment rate, protocol adherence, loss to follow-up, and cost per participant.
Discussion:
This pilot study will assess the feasibility of conducting a blinded randomized controlled trial of postoperative antibiotic therapy in children with perforated appendicitis. To date, only one randomized trial has addressed this question, but it was limited by its single-center design, lack of blinding, and susceptibility to ascertainment bias and other methodological concerns. Findings from this pilot will inform the design of a larger, multicenter study with rigorous blinding and standardized outcome assessment to determine whether piperacillin-tazobactam or ceftriaxone and metronidazole provides superior outcomes.
Trial Registration:
ClinicalTrials.gov: NCT05943223.
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