title: Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled multicenter trial.
abstract: OBJECTIVE
  To compare repeat intravenous (i.v.) dosing of ondansetron 4 mg with placebo for the treatment of postoperative nausea and vomiting (PONV) in patients for whom prophylactic, preoperative ondansetron 4 mg i.v. was inadequate
  
  
  METHODS
  Randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  Ten outpatient surgical centers in the United States.
  
  
  METHODS
  2,199 male and female ASA physical status I, II, and III patients > or = 12 years old scheduled to undergo outpatient surgical procedures and receive nitrous oxide-based general anesthesia.
  
  
  METHODS
  Ondansetron 4 mg i.v. was administered to all patients before induction of general anesthesia. Patients who experienced PONV or requested antiemetic therapy within 2 hours after discontinuation of inhaled anesthesia were randomized (1:1) to either a repeat i.v. ondansetron 4 mg dose or placebo.
  
  
  RESULTS
  Of the 2,199 patients prophylactically treated with ondansetron 4 mg before anesthesia induction, 1,771 (80.5%) did not experience PONV or request antiemetic therapy during the 2 hours following discontinuation of anesthesia. Of the 428 patients who experienced PONV or requested antiemetic therapy during the same period, and were randomized to additional treatment (214 randomized to ondansetron, 214 randomized to placebo), the incidence of complete response (no emesis, no rescue medication, no study withdrawal) was similar for both ondansetron-randomized and placebo-randomized groups for the 2-hour (34% and 43%, respectively, p = 0.074) and 24-hour (28% and 32%, respectively, p = 0.342) postrandomization study periods. Repeat ondansetron dosing was not more effective than placebo in controlling either postoperative emesis or the severity/duration of postoperative nausea. The administration of an additional dose of ondansetron 4 mg postoperatively did not result in an increased incidence of adverse effects.
  
  
  CONCLUSIONS
  In patients for whom preoperative prophylaxis with ondansetron 4 mg i.v. is not successful, a repeat dose of ondansetron 4 mg i.v. in the postanesthesia care unit does not appear to offer additional control of PONV.
authors.affiliation: Department of Anesthesiology, University of Kansas Medical Center, Kansas City 66160-7415, USA. akovac@kumc.edu
authors.forename: A L
authors.initials: AL
authors.lastname: Kovac
authors.forename: T A
authors.initials: TA
authors.lastname: O'Connor
authors.forename: M H
authors.initials: MH
authors.lastname: Pearman
authors.forename: L J
authors.initials: LJ
authors.lastname: Kekoler
authors.forename: D
authors.initials: D
authors.lastname: Edmondson
authors.forename: V L
authors.initials: VL
authors.lastname: Baughman
authors.forename: J J
authors.initials: JJ
authors.lastname: Angel
authors.forename: C
authors.initials: C
authors.lastname: Campbell
authors.forename: H G
authors.initials: HG
authors.lastname: Jense
authors.forename: M
authors.initials: M
authors.lastname: Mingus
authors.forename: M B
authors.initials: MB
authors.lastname: Shahvari
authors.forename: M R
authors.initials: MR
authors.lastname: Creed
mesh_terms: D000293:Adolescent; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D017294:Ondansetron / Q000008:administration & dosage* / Q000627:therapeutic use; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D017294:Ondansetron