Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis. This project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups; * Group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline (placebo) eight and sixteen hours after the initial dose, respectively. * Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively. Group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place. The aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing: * Duration of hospital stay from operation until discharge, based on a standardised discharge criteria. * Development of wound infection or requirement of antibiotics in the six weeks post-operation * Need for re-admission. Information will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
IV doses of metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g). One dose for study arm, two for comparative arm.
Monash Medical Centre
Clayton, Victoria, Australia
Presence of post-operative infection in the six weeks following appendectomy
Defined by wound infection, fever (\>38.5) or evidence of sepsis.
Time frame: 6 weeks
Requirement of further antibiotic therapy in the six weeks following appendectomy
Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.
Time frame: 6 weeks
Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria
Discharge criteria: Pain adequately controlled with oral analgesia Tolerating full diet Afebrile
Time frame: 1 week
Re-admission in the six weeks following appendectomy
Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.
Time frame: 6 weeks
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