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Paul F. White - One of the best experts on this subject based on the ideXlab platform.
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comparative efficacy of acustimulation reliefband versus ondansetron Zofran in combination with droperidol for preventing nausea and vomiting
Anesthesiology, 2002Co-Authors: Paul F. White, Tijani Issioui, Stephanie B Jones, Jayne E Coleman, Jean P Waddle, Scott D Markowitz, Margarita Coloma, Amy R Macaluso, Caleb IngAbstract:Background Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand® to ondansetron (Zofran®) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. Methods A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand®; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand®; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand®. The incidences of postoperative nausea and vomiting, as well as the need for “rescue” antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. Results Use of the ReliefBand® in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand® was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 ± 10 vs. 70 ± 20) and patient satisfaction (94 ± 10 vs. 75 ± 22) scores were significantly higher in the combination group versus the ondansetron group. There were no significant differences between the ReliefBand® and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. Conclusions The ReliefBand® compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery.
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Need information on "Off-Label" uses of anesthetic drugs? Just ask the pharmaceutical representative!
Anesthesia and analgesia, 2002Co-Authors: Paul F. WhiteAbstract:he recent Food and Drug Administration (FDA)action in placing a “Black Box” warning on theuse of small-dose droperidol for the preventionof postoperative nausea and vomiting has raised med-icolegal concerns among practicing anesthesiologistsand nurse anesthetists who choose to continue usingthis highly cost-effective antiemetic without perform-ing a screening 12-lead electrocardiogram (ECG) and3 hours of postadministrative monitoring as recom-mended in the package insert (1). Although there is awealth of published information in the peer-reviewedmedical literature establishing the comparable safetyand efficacy of small-dose droperidol (0.625–1.25 mg)to other more costly antiemetic drugs (e.g., ondanse-tron), this type of information is not always availablein the FDA-approved and manufacturer-generatedpackage insert. In some cases, the optimal use of aspecific drug may actually contradict what is recom-mended in the package insert (2). For example, theinsert states that ondansetron (Zofran
Paul J. Hesketh - One of the best experts on this subject based on the ideXlab platform.
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Stratified, Randomized, Double-Blind Comparison of Intravenous Ondansetron Administered as a Multiple-Dose Regimen Versus Two Single-Dose Regimens in the Prevention of Cisplatin-Induced Nausea and Vomiting
2016Co-Authors: M. Beck, Paul J. Hesketh, Stefan Madajewicz, Rudolph M. Navari, Kelly Pendergrass, Eric P. Lester, Julie A. Kish, William K. Murphy, John D. Hainsworth, David R. GAbstract:Purpose: This study compares the efficacy and safety of two single-dose regimens with the approved three-dose regimen of ondansetron in the prevention of cispla-tin-induced emesis. Patients and Methods: This multicenter study was a stratified, randomized, double-blind, and parallel group design. Chemotherapy-naive inpatients were random-ized to receive intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park, NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg dose followed by two saline doses that began 30 minutes before cisplatin administration. Cisplatin (high-dose-a 100 mg/m2 or medium-dose 50 to 70 mg/m 2) was given as a single infusion (s 3 hours). Patients were monitored for emetic episodes, adverse events, and laboratory safet
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A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1994Co-Authors: Paul J. Hesketh, Julie A. Kish, William K. Murphy, John D. Hainsworth, W. H. Harvey, W G Harker, T Beck, Thomas J. Ryan, L J Bricker, B HaleyAbstract:PURPOSEThis study compares the efficacy and safety of ondansetron alone with that of ondansetron plus dexamethasone in the prevention of emesis induced by high-dose cisplatin (> or = 100 mg/m2).PATIENTS AND METHODSThis multicenter study used a randomized, double-blind, parallel-group design. Chemotherapy-naive patients were randomized to receive intravenous (IV) ondansetron (Zofran, Cerenex Pharmaceuticals, Research Triangle Park, NC) 0.15 mg/kg for three doses every 4 hours beginning 30 minutes before cisplatin administration either alone or in combination with dexamethasone 20 mg administered 45 minutes before cisplatin. Cisplatin (> or = 100 mg/m2) was administered as a single infusion (< or = 3 hours). Patients were monitored for emetic episodes (EEs), adverse events, and laboratory safety parameters for 24 hours after cisplatin administration.RESULTSA total of 275 patients were enrolled. Of these, 245 were assessable for efficacy. Patients who received ondansetron plus dexamethasone had a higher comp...
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Stratified, randomized, double-blind comparison of intravenous ondansetron administered as a multiple-dose regimen versus two single-dose regimens in the prevention of cisplatin-induced nausea and vomiting.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1992Co-Authors: T Beck, Paul J. Hesketh, Stefan Madajewicz, Rudolph M. Navari, Kelly Pendergrass, Eric P. Lester, Julie A. Kish, William K. Murphy, John D. Hainsworth, David R. GandaraAbstract:PURPOSEThis study compares the efficacy and safety of two single-dose regimens with the approved three-dose regimen of ondansetron in the prevention of cisplatin-induced emesis.PATIENTS AND METHODSThis multicenter study was a stratified, randomized, double-blind, and parallel group design. Chemotherapy-naive inpatients were randomized to receive intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park, NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg dose followed by two saline doses that began 30 minutes before cisplatin administration. Cisplatin (high-dose > or = 100 mg/m2 or medium-dose 50 to 70 mg/m2) was given as a single infusion (< or = 3 hours). Patients were monitored for emetic episodes, adverse events, and laboratory safety parameters for 24 hours after cisplatin administration.RESULTSA total of 699 patients (359 high-dose, 340 medium-dose) were enrolled. Of these, 618 were assessable for efficacy (15 ineligible, 66 protocol deviations). The 32-mg dose wa...
Caleb Ing - One of the best experts on this subject based on the ideXlab platform.
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comparative efficacy of acustimulation reliefband versus ondansetron Zofran in combination with droperidol for preventing nausea and vomiting
Anesthesiology, 2002Co-Authors: Paul F. White, Tijani Issioui, Stephanie B Jones, Jayne E Coleman, Jean P Waddle, Scott D Markowitz, Margarita Coloma, Amy R Macaluso, Caleb IngAbstract:Background Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand® to ondansetron (Zofran®) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. Methods A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand®; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand®; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand®. The incidences of postoperative nausea and vomiting, as well as the need for “rescue” antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. Results Use of the ReliefBand® in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand® was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 ± 10 vs. 70 ± 20) and patient satisfaction (94 ± 10 vs. 75 ± 22) scores were significantly higher in the combination group versus the ondansetron group. There were no significant differences between the ReliefBand® and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. Conclusions The ReliefBand® compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery.
Tania M Vila - One of the best experts on this subject based on the ideXlab platform.
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The Role of Ondansetron in the Treatment of Schizophrenia
Annals of Pharmacotherapy, 2010Co-Authors: Allison C Bennett, Tania M VilaAbstract:Objective:To evaluate the efficacy of ondansetron for the treatment of schizophrenia.Data Sources:Searches of MEDLINE (1950–March 2010) and Google Scholar were performed. Key search terms included ondansetron, Zofran, serotonin antagonists, 5-HT, serotonin receptor, and schizophrenia.Study Selection and Data Extraction:All articles published in English identified from the data sources were evaluated. All studies and case reports evaluating ondansetron for the treatment of schizophrenia were reviewed.Data Synthesis:Six clinical trials, including 3 double-blind, randomized trials, and 2 case reports pertinent to ondansetron use in schizophrenia, were identified. Ondansetron daily doses ranged from 4 to 16 mg, with doses administered once or twice daily. Ondansetron was used as monotherapy in 3 trials and as an adjunct to therapy with clozapine, haloperidol, or risperidone, respectively, in 3 trials. Studies were of varying durations, ranging from a single-dose study with a 3-hour follow-up to three 12-week ...
John D. Hainsworth - One of the best experts on this subject based on the ideXlab platform.
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Stratified, Randomized, Double-Blind Comparison of Intravenous Ondansetron Administered as a Multiple-Dose Regimen Versus Two Single-Dose Regimens in the Prevention of Cisplatin-Induced Nausea and Vomiting
2016Co-Authors: M. Beck, Paul J. Hesketh, Stefan Madajewicz, Rudolph M. Navari, Kelly Pendergrass, Eric P. Lester, Julie A. Kish, William K. Murphy, John D. Hainsworth, David R. GAbstract:Purpose: This study compares the efficacy and safety of two single-dose regimens with the approved three-dose regimen of ondansetron in the prevention of cispla-tin-induced emesis. Patients and Methods: This multicenter study was a stratified, randomized, double-blind, and parallel group design. Chemotherapy-naive inpatients were random-ized to receive intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park, NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg dose followed by two saline doses that began 30 minutes before cisplatin administration. Cisplatin (high-dose-a 100 mg/m2 or medium-dose 50 to 70 mg/m 2) was given as a single infusion (s 3 hours). Patients were monitored for emetic episodes, adverse events, and laboratory safet
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A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1994Co-Authors: Paul J. Hesketh, Julie A. Kish, William K. Murphy, John D. Hainsworth, W. H. Harvey, W G Harker, T Beck, Thomas J. Ryan, L J Bricker, B HaleyAbstract:PURPOSEThis study compares the efficacy and safety of ondansetron alone with that of ondansetron plus dexamethasone in the prevention of emesis induced by high-dose cisplatin (> or = 100 mg/m2).PATIENTS AND METHODSThis multicenter study used a randomized, double-blind, parallel-group design. Chemotherapy-naive patients were randomized to receive intravenous (IV) ondansetron (Zofran, Cerenex Pharmaceuticals, Research Triangle Park, NC) 0.15 mg/kg for three doses every 4 hours beginning 30 minutes before cisplatin administration either alone or in combination with dexamethasone 20 mg administered 45 minutes before cisplatin. Cisplatin (> or = 100 mg/m2) was administered as a single infusion (< or = 3 hours). Patients were monitored for emetic episodes (EEs), adverse events, and laboratory safety parameters for 24 hours after cisplatin administration.RESULTSA total of 275 patients were enrolled. Of these, 245 were assessable for efficacy. Patients who received ondansetron plus dexamethasone had a higher comp...
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Stratified, randomized, double-blind comparison of intravenous ondansetron administered as a multiple-dose regimen versus two single-dose regimens in the prevention of cisplatin-induced nausea and vomiting.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1992Co-Authors: T Beck, Paul J. Hesketh, Stefan Madajewicz, Rudolph M. Navari, Kelly Pendergrass, Eric P. Lester, Julie A. Kish, William K. Murphy, John D. Hainsworth, David R. GandaraAbstract:PURPOSEThis study compares the efficacy and safety of two single-dose regimens with the approved three-dose regimen of ondansetron in the prevention of cisplatin-induced emesis.PATIENTS AND METHODSThis multicenter study was a stratified, randomized, double-blind, and parallel group design. Chemotherapy-naive inpatients were randomized to receive intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park, NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg dose followed by two saline doses that began 30 minutes before cisplatin administration. Cisplatin (high-dose > or = 100 mg/m2 or medium-dose 50 to 70 mg/m2) was given as a single infusion (< or = 3 hours). Patients were monitored for emetic episodes, adverse events, and laboratory safety parameters for 24 hours after cisplatin administration.RESULTSA total of 699 patients (359 high-dose, 340 medium-dose) were enrolled. Of these, 618 were assessable for efficacy (15 ineligible, 66 protocol deviations). The 32-mg dose wa...