OBJECTIVE:

To test the hypothesis that short-term use of ibuprofen increases asthma morbidity in children.

METHODS:

A randomized, double-blind, acetaminophen-controlled clinical trial was conducted. Children who had asthma and a febrile illness were randomly assigned to receive either acetaminophen suspension or ibuprofen suspension for fever control. Rates of hospitalization and outpatient visits for asthma during follow-up were compared by randomization group.

RESULTS:

A total of 1879 children receiving asthma medications were studied. Rates of hospitalization for asthma did not vary significantly by antipyretic assignment; compared with children who were randomized to acetaminophen, the relative risk for children who were assigned to ibuprofen was 0.63 (95% confidence interval: 0.25-1.6). However, the risk of an outpatient visit for asthma was significantly lower in the ibuprofen group; compared with children who were randomized to acetaminophen, the relative risk for children who were assigned to ibuprofen was 0.56 (95% confidence interval: 0.34-0.95).

CONCLUSIONS:

Rather than supporting the hypothesis that ibuprofen increases asthma morbidity among children who are not known to be sensitive to aspirin or other nonsteroidal antiinflammatory drugs, these data suggest that compared with acetaminophen, ibuprofen may reduce such risks. Whether the observed difference in morbidity according to treatment group is attributable to increased risk after acetaminophen use or a decrease after ibuprofen cannot be determined. These data provide evidence of the relative safety of ibuprofen use in children with asthma.