University of Michigan
Department of Pediatrics
Evidence-Based Pediatrics Web Site

Question

• In children older than 1 year with uncomplicated acute otitis media (AOM), does pain management with the availability of a safety net antibiotic prescription (SNAP) alter antibiotic usage rates?

Clinical Bottom Lines

1. In a defined population, with uncomplicated AOM, the use of a protocol that includes pain management and SNAP can lower antibiotic use. For every 1.5 patients enrolled, antibiotic use was decreased by 1 prescription.
   
2. Parents who did not fill the SNAP were largely willing to try pain control alone in the future.
   
3. The effect of using this protocol on the incidence of suppurative complications is speculative. No complications were reported in those enrolled in the study receiving follow-up at 5 to 10 days.

Summary of Key Evidence

1. 11 pediatric offices of the Cincinnati Pediatric Research Group participated in the recruitment of study participants. Children, ages 1 to 12 years, with uncomplicated AOM were eligible. Of the 199 families approached, 5 declined to participate, leaving 194 subjects for study. This allowed for statistical power of 80% to detect a 5% reduction in antibiotic use.1
   
2. Otitis media was a clinic diagnosis defined as: 1) a bulging or pustular TM on otoscopy or 2) red TM with decreased mobility by pneumatic otoscopy or tympanogram.
   
3. Children were excluded for "complicated" AOM, e.g. temperature >101.5, symptoms for >48 hours, toxic appearance, TM perforation or impending perforation, AOM within the last 3 months, or chronic condition limiting the child's ability to clear an infection.
   
4. Study participants were given written information and samples of ibuprofen, acetaminophen, and otic drops at no expense. They were provided the SNAP to be filled if symptoms were worse or not better after 48 hours.
   
5. The study nurse conducted a structured phone follow-up interview 5-10 days after enrollment. Main outcome measures were: if the SNAP was filled compared with antibiotic use for previous AOM and parents' future willingness to treat AOM with pain medicine alone.
   
6. 69% of families did not fill the SNAP (95%CI: 61.7%-75.5%). Of those who did not fill the SNAP, 97% were willing to treat the next AOM with pain medication alone (95%CI: 94.4-100%). All parents whose child had previous AOM reported antibiotic use; only 33% of this population used antibiotics to treat this episode.
   
7. Demographic variables did not account for differences in parents' behavior. Previous episodes of AOM were the only statistically significant variable associated with increased rate of SNAP use. Parents of children who had had 2 or more AOM in the past were more likely to fill the SNAP.
   
8. Suppurative complications were not reported and the time period for follow-up was limited.

Additional Comments

• The use of pain control with available SNAP appears to alter parents perception of the need for antibiotics for the treatment of future episodes of AOM.
  
• The recent AAP guidelines for management of AOM include:
  1) A strong recommendation for the treatment of pain reducers especially during the first 24 hours of illness.
  2) The option to consider an observation period in uncomplicated AOM (children 6mo-2yrs with non-severe illness AND uncertain diagnosis; children >2rs without severe symptoms OR uncertain diagnosis).2

Citation

1. Siegel RM, Kiely M, Bien JP, Joseph EC, Davis JB, Mendel SG, Pestian JP, DeWitt TG.
   Treatment of Otitis Media with Observation and a Safety-Net Antibiotic Prescription.
   Pediatrics 2003; 112: 527-531.
   
2. Clinical Practice Guideline: Diagnosis and Management of Acute Otitis Media.
   Pediatrics 2004; 113: 1451-1456.

CAT Author: Michelle Macy, MD

CAT Appraisers: Robert Schumacher , MD

Date appraised: May 12, 2004