title: A prospective, randomized, double-blind controlled trial of acetaminophen and diphenhydramine pretransfusion medication versus placebo for the prevention of transfusion reactions.
abstract: BACKGROUND
  Acetaminophen and diphenhydramine are commonly used as pretransfusion medications to prevent transfusion reactions. The purpose of this study was to prospectively compare the risk of transfusion reactions in hematology/oncology patients who receive acetaminophen with diphenhydramine or placebo before transfusion.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled transfusion reaction study of 315 eligible patients was performed. Inclusion criteria were patients aged 18 to 65 years admitted to the leukemia or bone marrow transplant (BMT) services. Patients were excluded if they had a known allergy to either acetaminophen or diphenhydramine or had a documented history of a febrile or allergic transfusion reaction. All blood products were administered using a leukofilter. Study medications were given 30 minutes before transfusions and no other acetaminophen or diphenhydramine was given within 4 hours of administration of the study medications. Patients were monitored for the development of reaction symptoms within 4 hours after the transfusion.
  
  
  RESULTS
  A total of 154 active drug patients were compared to 161 placebo patients. There was no significant difference in the overall risk of transfusion reactions between the two groups. However, analysis of specific reaction types revealed a significant decrease in the risk of febrile reactions when pretransfusion medication is used in addition to bedside leukoreduction.
  
  
  CONCLUSIONS
  Pretransfusion medication of leukemia or BMT patients without a history of transfusion reaction does not decrease the overall risk of transfusion reactions. However, pretransfusion medication may decrease the risk of febrile nonhemolytic transfusion reactions to leukoreduced blood products.
authors.affiliation: Department of Pharmacy, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA. lakenned@wfubmc.edu
authors.forename: LeAnne D
authors.initials: LD
authors.lastname: Kennedy
authors.forename: L Douglas
authors.initials: LD
authors.lastname: Case
authors.forename: David D
authors.initials: DD
authors.lastname: Hurd
authors.forename: Julia M
authors.initials: JM
authors.lastname: Cruz
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Pomper
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004155:Diphenhydramine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000209:etiology / Q000517:prevention & control*; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology / Q000517:prevention & control*; D047589:Leukocyte Reduction Procedures; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000628:therapy; D011292:Premedication; D011446:Prospective Studies; D065227:Transfusion Reaction
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D006634:Histamine H1 Antagonists; D000082:Acetaminophen; D004155:Diphenhydramine