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Completed Prospective Studies Intravenous versus Intravenous-Oral Antibiotics for Perforated Appendicitis

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 Children's Mercy Kansas City 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 Simon.

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 abdomen.

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 groups.

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