Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
- Conditions
- Otitis Media
- Registration Number
- NCT00250900
- Lead Sponsor
- Yale University
- Brief Summary
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription
- Detailed Description
We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media
- clinician suspicion or diagnosis of a concurrent bacterial infection
- patient appeared "toxic" as determined by the PEM clinician
- patient was hospitalized
- history of compromised immunity
- patient was treated with antimicrobials in the preceding seven days
- either tympanic membrane was perforated
- myringotomy tubes were present
- uncertain access to medical care
- primary language of the parent or guardian was neither English nor Spanish
- prior enrollment in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of each group that filled the antibiotic prescription
- Secondary Outcome Measures
Name Time Method Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States