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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00250900

Enrollment

240

Registered

2005-11-08

Start date

2004-07-31

Completion date

2005-08-31

Last updated

2006-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

Otitis, Antibiotic, Prescription

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.

Interventions

BEHAVIORALPrescription Fill Status

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

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

Design outcomes

Primary

Measure	Time frame
Proportion of each group that filled the antibiotic prescription	—

Secondary

Measure	Time frame
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026