Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Otitis Media
- Sponsor
- Yale University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Proportion of each group that filled the antibiotic prescription
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Proportion of each group that filled the antibiotic prescription
Secondary Outcomes
- Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits