TY - JOUR
T1 - Results of a pilot trial comparing prolonged intravenous antibiotics with sequential intravenous/oral antibiotics for children with perforated appendicitis
AU - Rice, Henry E.
AU - Brown, Rebecca L.
AU - Gollin, Gerald
AU - Caty, Michael G.
AU - Gilbert, James
AU - Skinner, Michael A.
AU - Glick, Philip L.
AU - Azizkhan, Richard G.
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2001
Y1 - 2001
N2 - Hypothesis: For children with perforated appendicitis, the use of a prolonged course of intravenous (IV) antibiotics is equivalent to a short course of IV antibiotics followed by sequential conversion to oral (PO) antibiotics. Design: Prospective, randomized, clinical trial. Setting: Multicenter study in tertiary children's hospitals. Patients: Children (aged 5-18 years) with perforated appendicitis found at laparotomy. Intervention: Children were randomized after appendectomy either to a 10-day course of a combination of IV ampicillin, gentamicin sulfate, and clindamycin (n= 10); or to a short course of a combination of IV ampicillin, gentamicin, and clindamycin, followed by conversion to a combination of PO amoxicillin and clavulanate potassium plus metronidazole (n = 16). Main Outcome Measures: The primary outcome measure was clinical success, which was rated as complete, partial, or failure. Secondary outcome measures included return of oral intake, duration of fever, return of normal white blood cell count, and patient charges. Treatment equivalence was determined using confidence interval analysis. Results: We found treatment equivalence between the IV and IV/PO groups, with 6 (60%) complete and 4 (40%) partial successes for the 10 patients in the IV group and 15 (94%) complete and 1 (6%) partial successes for the 16 patients in the IV/PO group (P≤.05). There was no difference in return of oral intake, duration of fever, or return of normal white blood cell count between the groups. Conversion to oral therapy results in savings of approximately $1500 per case. Conclusion: There is treatment equivalence between prolonged IV therapy and IV therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis.
AB - Hypothesis: For children with perforated appendicitis, the use of a prolonged course of intravenous (IV) antibiotics is equivalent to a short course of IV antibiotics followed by sequential conversion to oral (PO) antibiotics. Design: Prospective, randomized, clinical trial. Setting: Multicenter study in tertiary children's hospitals. Patients: Children (aged 5-18 years) with perforated appendicitis found at laparotomy. Intervention: Children were randomized after appendectomy either to a 10-day course of a combination of IV ampicillin, gentamicin sulfate, and clindamycin (n= 10); or to a short course of a combination of IV ampicillin, gentamicin, and clindamycin, followed by conversion to a combination of PO amoxicillin and clavulanate potassium plus metronidazole (n = 16). Main Outcome Measures: The primary outcome measure was clinical success, which was rated as complete, partial, or failure. Secondary outcome measures included return of oral intake, duration of fever, return of normal white blood cell count, and patient charges. Treatment equivalence was determined using confidence interval analysis. Results: We found treatment equivalence between the IV and IV/PO groups, with 6 (60%) complete and 4 (40%) partial successes for the 10 patients in the IV group and 15 (94%) complete and 1 (6%) partial successes for the 16 patients in the IV/PO group (P≤.05). There was no difference in return of oral intake, duration of fever, or return of normal white blood cell count between the groups. Conversion to oral therapy results in savings of approximately $1500 per case. Conclusion: There is treatment equivalence between prolonged IV therapy and IV therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis.
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U2 - 10.1001/archsurg.136.12.1391
DO - 10.1001/archsurg.136.12.1391
M3 - Article
C2 - 11735866
AN - SCOPUS:0035213257
SN - 0004-0010
VL - 136
SP - 1391
EP - 1395
JO - Archives of Surgery
JF - Archives of Surgery
IS - 12
ER -