Objective: To determine if intramuscular (IM) penicillin is more effective than oral (PO) amoxicillin in the early outpatient treatment of pediatric patients with presumed bacterial pneumonia.
Methods: Prospective, randomized, evaluator-blinded, clinical trial.
Setting: Pediatric emergency department (ED) of an urban children's hospital.
Patients: ED patients with radiographically confirmed pneumonias managed as outpatients. Patients with chronic illnesses, wheezing, allergy to amoxicillin or penicillin, recent antibiotic therapy, or concurrent diagnosis of another febrile illness were excluded.
Interventions: Patients received either a two-day supply of PO amoxicillin (50 mg/kg/day divided tid), or an IM injection of procaine penicillin G (PPG) (50,000 units/kg). They had a complete blood count (CBC), blood culture, and nasopharyngeal swab for viral culture done at initial visit. They returned in 24 to 36 hours for reevaluation.
Outcome measures: The main measures were temperature, respiratory rate, and general appearance score; additional measures were accessory muscle use, pulse oximetry, parental report of activity/oral intake.
Results: One hundred seventy patients were enrolled. There were no significant differences between the two groups at initial or follow-up visits with respect to temperature, respiratory rate, accessory muscle use, pulse oximetry, or parental reports of activity level and oral intake. Only in the general appearance of children less than two years of age did there appear to be a difference (P = 0.03). When subanalysis excluded patients with positive viral studies (n = 17) or chest x-rays "reread" by an attending pediatric radiologist as "no infiltrate" (n = 29), this difference disappeared (P = 0.10). Three patients in the PO group, and five in the IM group failed by all three main outcome measures (P = 1.00). Four patients in the PO group, and five in the IM group were hospitalized at the follow-up visit (P = 1.00).
Conclusion: There does not appear to be a significant difference between PO amoxicillin and IM penicillin in the early outpatient treatment of pediatric patients with presumed bacterial pneumonia.