IMPPACT (Intravenous Monotherapy For Postoperative Perforated Appendicitis In Children Trial) Randomized Clinical Trial Of Monotherapy Versus Multi-drug Antibiotic Therapy
*Justin Lee1, *Erin M Garvey1, *Nikkida Bundrant1, *Obiyo Osuchukwu2, *Angela Hargis-Villanueva1, *Charlene Dekonenko2, *Paul Kang3, *Wendy Jo Svetanoff2, Shawn St. Peter2, *Benjamin Padilla1, Daniel Ostlie1
1Phoenix Children's Hospital, Phoenix, AZ;2Children's Mercy Hospital, Kansas City, MO;3University of Arizona College of Public Health, Phoenix, AZ
OBJECTIVE(S): Perforated appendicitis is the most common cause of intra-abdominal abscess (IAA) in children. The literature on optimal postoperative antibiotic regimen has evolved in the last decade from triple-drug to two-drug ceftriaxone and metronidazole (CM). Recent retrospective studies have shown decreased infectious complications with monotherapy piperacillin-tazobatam (PT). To date prospective comparative data are lacking. Therefore, a prospective randomized trial comparing PT versus CM was conducted.METHODS: A multi-institutional prospective randomized trial was performed in children with perforated appendicitis comparing postoperative antibiotic regimens PT or CM. The primary outcome was 30-day postoperative IAA formation. Perforation was strictly defined as a hole in the appendix or fecalith in the abdomen, and documented with intraoperative photographs.RESULTS: 162 patients were enrolled during the study period. No difference in age, weight, or duration of presenting symptoms was identified. In addition, length of stay, duration of intravenous antibiotic treatment, discharge oral antibiotic treatment, or antibiotic-related complications did not differ between groups. Compared to the CM group, the PT group had significantly lower IAA rate (6.1% vs 23.8%, OR 4.80, p=0.002), lower postoperative computed tomography imaging (13.9% vs 29.3%, OR 2.57, p=0.030), and lower emergency room visits (8.8% vs 26.4%, OR 3.73, p=0.022). Multivariate logistic regression analysis found the use of CM versus PT (OR 9.21, p=0.021) to be the most significant predictor for developing IAA. CONCLUSIONS: In children with perforated appendicitis, postoperative monotherapy with PT is superior to standard multi-drug therapy with CM and does not increase antibiotic-related complications or antibiotic exposure duration.
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