Otitis Media Rx: What Impact of Wait-and-See?

September 13, 2006

NEW HAVEN, Conn. -- The use of antibiotics has been substantially reduced for children with acute otitis media, with little effect on outcomes, by contingency prescriptions that recommend a delay in filling.

NEW HAVEN, Conn., Sept. 12 -- The use of antibiotics has been substantially reduced for children with acute otitis media, with little effect on outcomes, by contingency prescriptions that recommend a delay in filling.

These watch-and-wait antibiotics prescriptions, which expire in three days, are accompanied by verbal and written advice, instructing parents to fill only if the "child is not better or is worse 48 hours (two days) after today's visit."

In a study of parents given wait-and-see antibiotics prescriptions in an emergency department, 62% did not fill them compared with 13% given a standard prescription with advice to fill immediately. No serious adverse events were reported for any of the patients in the study, according to a report in the Sept. 13 issue of the Journal of the American Medical Association.

Wait-and-see prescriptions conflict with common wisdom among most pediatricians in the U.S., who have been trained to routinely prescribe antibiotics for acute otitis media and believe that many parents expect a prescription, said a team headed by David Spiro, M.D., formerly of Yale here and now at Oregon Health Science University in Portland. On the other hand, a small minority of practitioners who care for children regularly use watchful waiting.

Parents and children arriving at an emergency department probably do not have an established relationship with the treating physician as they would in an office-based practice. "Ours is the first trial to enroll patients in the setting of an emergency department," Dr. Spiro said.

In a one-year randomized controlled trial, 283 children with acute otitis media, ages six months to 12 years, were randomly assigned to either an antibiotic prescription with watchful-waiting advice (138 children) or a standard antibiotic prescription (145 children).

Children were excluded if they had a suspected or actual additional intercurrent bacterial infection; appeared "toxic" as determined by the physician, were hospitalized or immunocompromised, had antibiotic treatment in the preceding seven days, had either myringotomy tubes or a perforated eardrum; had uncertain access to medical care; and the primary language of the parents or guardian was neither English nor Spanish.

All patients received ibuprofen and otic analgesic drops for use at home, and all were given an antibiotic prescription (mainly amoxicillin) that would expire in three days after the child's visit.

Watchful-waiters were given written and verbal instructions "not to fill the antibiotic prescription unless your child is not better or is worse 48 hours (two days) after today's visit." Parents of children randomized to the standard prescription group were told to start the antibiotic immediately.

A research assistant, blinded to group assignment, conducted structured phone interviews four to six, 11 to 14, and 30 to 40 days after enrollment to determine outcomes.

Of the watchful waiters, both fever (relative risk 2.95; 95% confidence interval. 1.75-4.99; P