Results of a pilot trial comparing prolonged intravenous antibiotics with sequential intravenous/oral antibiotics for children with perforated appendicitis.
OBJECTIVE
For children with perforated appendicitis, the use of a prolonged course of intravenous (i.v.) antibiotics is equivalent to a short course of i.v. antibiotics followed by sequential conversion to oral (PO) antibiotics.


METHODS
Prospective, randomized, clinical trial.


METHODS
Multicenter study in tertiary children's hospitals.


METHODS
Children (aged 5-18 years) with perforated appendicitis found at laparotomy.


METHODS
Children were randomized after appendectomy either to a 10-day course of a combination of i.v. ampicillin, gentamicin sulfate, and clindamycin (n = 10); or to a short course of a combination of i.v. ampicillin, gentamicin, and clindamycin, followed by conversion to a combination of p.o. amoxicillin and clavulanate potassium plus metronidazole (n = 16).


METHODS
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 i.v. and i.v./p.o. groups, with 6 (60%) complete and 4 (40%) partial successes for the 10 patients in the i.v. group and 15 (94%) complete and 1 (6%) partial successes for the 16 patients in the i.v./p.o. group (P< or =.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.


CONCLUSIONS
There is treatment equivalence between prolonged i.v. therapy and i.v. therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis.
Rice
H E
HE
Division of Pediatric Surgery, Campus Box 3815, Duke University Medical Center, Durham, NC 27710, USA. rice0017@mc.duke.edu
Brown
R L
RL
Gollin
G
G
Caty
M G
MG
Gilbert
J
J
Skinner
M A
MA
Glick
P L
PL
Azizkhan
R G
RG
D000284:Administration, Oral; D000293:Adolescent; D000667:Ampicillin / Q000008:administration & dosage / Q000627:therapeutic use; D001064:Appendicitis / Q000150:complications / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D019818:Clavulanic Acid / Q000008:administration & dosage / Q000627:therapeutic use; D002981:Clindamycin / Q000008:administration & dosage / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D007416:Intestinal Perforation / Q000209:etiology*; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D012422:Rupture, Spontaneous
D005839:Gentamicins; D008795:Metronidazole; D019818:Clavulanic Acid; D002981:Clindamycin; D000667:Ampicillin