Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Yale University240 enrolled

Overview

To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Otitis Media

Interventions

Prescription Fill StatusBEHAVIORAL

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University

New Haven, Connecticut, United States

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

Data from ClinicalTrials.gov

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