Boston University Fever Study (BUFS)

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 and Study Staff

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

Study Details

Source of Funding:

McNeil Consumer Products Company

Study Period:

September 1990 to March 1994

Publications

  • Lesko SM. The safety of ibuprofen suspension in children. Int J Clin Pract Suppl 2003;135:50-3.
  • Lesko SM, Louik C, Vezina RM, Mitchell AA. Asthma morbidity after the short-term use of ibuprofen in children. Pediatrics 2002;109:e20.
  • Lesko SM, Mitchell AA. The safety of acetaminophen and ibuprofen among children younger than two years old. Pediatrics 1999;104(4):e39.
  • Lesko SM, Mitchell AA. Renal function after short-term ibuprofen use in infants and children. Pediatrics 1997;100:954-7.
  • Lesko SM, Mitchell AA. Pediatric ibuprofen and leukopenia [letter to the editor]. J Am Med Assoc 1996;275:986.
  • Mitchell AA, Lesko SM. When a randomised controlled trial is needed to assess drug safety: the case of paediatric ibuprofen. Drug Saf 1995;13:15-24.
  • Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial. J Am Med Assoc 1995;273:929-33.
  • Mitchell AA, Lesko S. Can practice-based experience define the safety of pediatric ibuprofen? California Pediatrician 1992;8:55-8.