Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled multicenter trial
| Autor: | Michael H. Pearman, Lance J. Kekoler, Holly G. Jense, John J. Angel, Mohammad B.G. Shahvari, Thomas A. O’Connor, Verna L. Baughman, Mary R. Creed, Melinda L. Mingus, Anthony L. Kovac, Donald Edmondson, Christina Campbell |
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| Rok vydání: | 1999 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.drug_class Placebo law.invention Ondansetron Randomized controlled trial Double-Blind Method law Multicenter trial medicine Antiemetic Humans Adverse effect Child business.industry Surgery Discontinuation Anesthesiology and Pain Medicine Anesthesia Injections Intravenous Postoperative Nausea and Vomiting Antiemetics Female medicine.symptom business Postoperative nausea and vomiting medicine.drug |
| Zdroj: | Journal of clinical anesthesia. 11(6) |
| ISSN: | 0952-8180 |
| Popis: | Study Objectives: To compare repeat intravenous (IV) 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 IV was inadequate Design: Randomized, double-blind, placebo-controlled study. Setting: Ten outpatient surgical centers in the United States. Patients: 2,199 male and female ASA physical status I, II, and III patients ≥12 years old scheduled to undergo outpatient surgical procedures and receive nitrous oxide-based general anesthesia. Interventions: Ondansetron 4 mg IV 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 IV ondansetron 4 mg dose or placebo. Measurements and Main 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 IV is not successful, a repeat dose of ondansetron 4 mg IV in the postanesthesia care unit does not appear to offer additional control of PONV. |
| Databáze: | OpenAIRE |
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