TDM Grand RoundsContact Dermatitis and Bradycardia in a Preterm Infant Given Tetracaine 4% GelTaddio, Anna BScPhm, MSc, PhD*; Lee, Charlene M. BScPhm, MSc†; Parvez, Boriana MD‡; Koren, Gideon MD§; Shah, Vibhuti MD∥ Author Information *Department of Pharmacy and Population Health Sciences, The Hospital for Sick Children, Toronto, Canada †Department of Pharmacy, Mount Sinai Hospital, Toronto, Canada ‡Division of Neonatology, Department of Paediatrics, The Hospital for Sick Children, Toronto, Canada §Division of Clinical Pharmacology and Toxicology, Departments of Paediatrics and Population Health Sciences, The Hospital for Sick Children, Toronto, Canada ∥Department of Paediatrics, Mount Sinai Hospital, Toronto, Canada Supported in part by the Canadian Society of Hospital Pharmacists Research and Education Foundation and The Hospital for Sick Children's Restracomp Training Award to C. Lee. A. Taddio is funded by the Canadian Institutes of Health Research New Investigator Award. There are no conflicts. All authors take full responsibility for the manuscript. Reprints: Dr A. Taddio, Department of Pharmacy, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8 (e-mail: [email protected]) Received for publication July 5, 2005; accepted October 11, 2005 Therapeutic Drug Monitoring: June 2006 - Volume 28 - Issue 3 - p 291-294 doi: 10.1097/01.ftd.0000195615.92591.9c Buy Metrics Abstract The use of analgesics for procedural pain management in the newborn infant has been steadily increasing during the past decade. With this trend of increased analgesic utilization, there is the potential for infants to suffer from drug-induced side effects. There also is the potential to wrongfully blame drugs for all adverse events that occur during analgesic use. Two adverse events that occurred in a neonate exposed to tetracaine gel and the probability that the adverse events were caused by the drug are presented. During administration of the topical local anesthetic tetracaine for analgesia during percutaneous central venous catheter placement, a preterm infant experienced bradycardia. Several hours later, a local cutaneous reaction that progressed to skin desquamation occurred at the site. The authors assessed the probability that tetracaine caused 2 adverse events using a validated adverse drug reaction probability scale by Naranjo et al. According to the algorithm developed by Naranjo et al, it was determined that bradycardia was unlikely caused by the drug; however, the dermal reaction was probably the result of the drug. The authors determined that tetracaine caused a serious local skin reaction, but not bradycardia, in a preterm infant. This is the first report of a serious skin reaction in a neonate treated with tetracaine. Based on these findings, tetracaine gel can continue to be used to treat pain in neonates with careful evaluation of the skin. © 2006 Lippincott Williams & Wilkins, Inc.