Intravenous versus Intravenous-Oral Antibiotics for
Perforated Appendicitis (Presented at the 2008 meeting of the
American Academy of Pediatrics)
This is a single institution, prospective, randomized clinical
trial involving patients who present to Chilren's Mercy
Hospitals and Clinics with perforated appendicitis. This will
be a definitive study.
Power calculation was based on the abscess rate in our
previously mentioned prospective study (Journal of Pediatric
Surgery 43:981-985, 2008). Our current rate is 18% or just
under one-fifth of the patients. A doubling of this rate to 36%
would place just over one-third of the patients at risk, which
would be unacceptable.
Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the
sample size is 74 patients in each arm. Therefore we will
anticipate enrolling 150 patients. Sample calculation was performed
with consultation from our hospital statistician, Dr. Steve
Subjects will be those children who undergo a laparoscopic
appendectomy as part of their routine care. Perforation will be
defined as an identifiable hole in the appendix or stool in the
The control group will receive our current standard care for
perforated appendicitis: ceftriaxone 50mg/kg once a day (maximum
dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose
= 1 gram). The length of antibiotic therapy will be a minimum
of five days.
At that time, if the patient is afebrile for at least 24 hours,
a white blood cell (WBC) count is obtained. If that is normal, the
antibiotics are discontinued and the patient is discharged. If the
WBC is elevated, they receive another two days before recheck. If
still elevated, they receive another three days (10 days total) and
a CT is obtained.
The experimental group receives the same combination of
antibiotics while in the hospital. Whenever the patient is
tolerating a regular diet, on oral pain medication and has been
afebrile for more than 12 hours, they are discharged on
oral antibiotics to complete a total seven-day antibiotic course.
The home antibiotic regimen is ampicillin/clavulanic acid
(Augmentin®). The Augmentin® dose will be 40mg/kg twice daily. The
primary endpoint is the rate of abscess formation between the two