In Reply:--Orman raises two important issues. The ideal route of preanesthetic drug administration in children has yet to be defined. Acceptability, effectiveness, and recovery profile are all factors in assessing a drug's utility as a preanesthetic medication. Nasal midazolam can be irritating and cause crying during the first minute after administration. Although we do not have formal statistics on parent/child acceptance, at our institution many parents ask to take nasal midazolam (the nose drops) home for use after surgery.
The second issue raised by Orman--drug use for unapproved indications in pediatric patients--is a serious and ethically disturbing matter. Pediatric anesthesiologists frequently administer medications for indications that are not included in the labeling approved by the Food and Drug Administration (the package insert). As Orman suggests, this practice places the physician at risk both legally and financially. In addition, the lack of approved drug labeling has made children "therapeutic orphans" (Table 1). Children of all ages deserve the same proof of drug safety and efficacy as that required for adults. It is ironic that most major laws supporting the FDA's role in regulating drugs through changes in the Food, Drug, and Cosmetic Act were a direct result of adverse drug events in pediatric patients. As child health advocates, we wonder why the FDA does not mandate appropriate pediatric testing as a routine part of the drug approval process. Although the lawyers and insurance carriers have a significant influence on how medicine is practiced, it is imperative that physicians caring for children do what clinical experience and common sense tell us is the right thing.
Peter J. Davis, M.D.; Associate Professor of Anesthesiology, Critical Care Medicine, and Pediatrics.
Julie A. Tome, M.D.; Assistant Professor of Anesthesiology; University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh; 3705 Fifth Avenue at DeSoto Street; Pittsburgh, Pennsylvania 15213-2583.
Francis X. McGowan, Jr., M.D.; Assistant Professor of Anesthesiology and Pediatrics; Department of Anesthesiology; Children's Hospital; 300 Longwood Avenue; Boston, Massachusetts 02115-5747.
Ira Todd Cohen, M.D.; Assistant Professor of Anesthesiology; Department of Anesthesiology; Children's Hospital National Medical Center; 111 Michigan Avenue, NW; Washington, D.C. 20010-2970.
(Accepted for publication March 9, 1995.)