Objectives:

To provide valid, stable, and clinically relevant information on the occurrence of rare but serious events among children receiving ibuprofen suspension for fever control.

Methods:

Physicians in private practice (pediatricians and family physicians) enrolled into the study patients with a febrile illness for whom they would normally recommend acetaminophen or ibuprofen (available by prescription only) for the control of fever. After obtaining written informed consent from a parent or guardian, the physician dispensed a bottle containing either acetaminophen or ibuprofen blindly. Four weeks after enrollment, the parents of each enrolled child received a questionnaire by mail inquiring as to the outcome of the illness and the occurrence of any complications or adverse reactions to treatment. Complications (or adverse reactions) requiring hospital admission were confirmed by review of the relevant medical records. The safety of pediatric ibuprofen was assessed by comparing the rates of serious complications and adverse reactions among acetaminophen and ibuprofen treated children.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Samuel M. Lesko, M.D., M.P.H., Co-Investigator

Source of funding:

McNeil Consumer Products Company

Study Period:

September 1990 - March 1994

Publications:

Link to Publications