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PubMed1998

Optimal selection of antiemetics in children receiving cancer chemotherapy.

Only a few studies have been carried out specifically on the prevention of nausea and vomiting in children receiving chemotherapy. In these patients older antiemetic drugs such as metoclopramide and phenothiazines had moderate efficacy and induced significant side effects, especially marked sedation and extrapyramidal reactions. In comparative trials the 5-HT3 receptor antagonists have shown better efficacy and tolerability than chlorpromazine or metoclopramide combined with dexamethasone. The combination of a 5-HT3 receptor antagonist plus dexamethasone is superior to a 5-HT3 receptor antagonist alone and should be the standard antiemetic prophylaxis in all paediatric patients receiving highly or moderately emetogenic chemotherapy. The optimal dose and scheduling of these antiemetic drugs need to be studied, as well as the antiemetic efficacy, in the prevention of chemotherapy-induced delayed and anticipatory emesis in children.

Antiemetics↗
PubMed1998

Methodology of antiemetic trials: response assessment, evaluation of new agents and definition of chemotherapy emetogenicity.

Establishing appropriate and practical methodology is a key to progress in the investigation of chemotherapy-induced nausea and vomiting. Critical issues include patient response assessment, proper trial design for evaluating new agents, and the definition of chemotherapy emetogenicity. In assessing antiemetic response, the primary end-point should be complete control of emesis and nausea. Emesis and nausea should be independently assessed with the period of observation defined (acute, delayed, anticipatory). Emesis can be evaluated by measuring the number of emetic episodes either by direct observation or by patient self-report using patient-completed diaries. Nausea should be measured by patient self-report with the standard parameters, including frequency and intensity. New antiemetic drug development should proceed in an orderly progression from open-label phase I-II trials defining tolerance and minimally fully effective dose to phase III comparative trials. A randomized, parallel, double-blind study is the preferred design for the latter, and the comparator arm should always include the current best available treatment. Antiemetic placebos are no longer acceptable with chemotherapy regimens known to produce emesis in a majority of patients. None of the emetogenic classifications proposed to date adequately accounts for all known important patient- and treatment-related prognostic variables. A modification of a recently reported schema is proposed for use in making antiemetic treatment recommendations and defining the emetogenic challenge in clinical trials.

Antiemetics↗
PubMed2000

Control of high-dose-cisplatin-induced emesis with an all-oral three-drug antiemetic regimen.

In this pilot trial, the antiemetic efficacy and tolerability of an all-oral antiemetic combination in the prevention of both acute and delayed nausea and vomiting following high-dose cisplatin was evaluated. Fifty-two patients receiving cisplatin (median dose 100 mg/m2) were entered. Patients received (1) 60 min prior to cisplatin: prochlorperazine spansule 15 mg, dexamethasone 20 mg, granisetron 2 mg; (2) 12 h after cisplatin: prochlorperazine spansule 15 mg, dexamethasone 10 mg; (3) on days 2 and 3: prochlorperazine spansule 15 mg b.i.d., dexamethasone 8 mg b.i.d.; (4) on days 4 and 5: dexamethasone 4 mg b.i.d. All antiemetics were administered orally. The study period was the 120 h after cisplatin administration. The primary efficacy end-point was complete control (no vomiting, retching or antiemetic rescue) of delayed emesis (24-120 h after cisplatin). Complete control of delayed emesis was achieved in 26 patients (53%). Nineteen patients (39%) noted no delayed nausea. Complete control of acute emesis (24 h after cisplatin) was attained in 44 patients (86%). The no nausea rate during the first 24 h was 74%. Overall, 39 patients (80%) were satisfied or very satisfied with their outcome. Treatment was well tolerated with infrequent and minor adverse events. In conclusion, an all-oral combination of granisetron, dexamethasone and prochlorperazine is a highly effective and well-tolerated regimen for preventing acute cisplatin-induced emesis. Control of delayed emesis was not better than with current standard treatment, and more effective approaches are needed.

Administration, Oral↗
PubMed1986

Emetic and antiemetic effects of opioids in the dog.

The emetic and antiemetic effects of opioid agonists were studied in awake dogs. The mu-agonists morphine, fentanyl and methadone, in sedative doses, prevented the emetic response to apomorphine and copper sulphate; only morphine induced emesis, at doses lower than those required to prevent emesis. The delta-agonist [D-Ala2,Met5]enkephalinamide (DALA) and [Leu5]enkephalin induced emesis in some of the dogs studied but had no antiemetic activity. The kappa-agonists bremazocine and ethylketocyclazocine (EKC) did not induce emesis but, at sedative doses, prevented the emetic response to apomorphine. The emetic effect of DALA was antagonized by naloxone in some dogs; the antiemetic effect of morphine, bremazocine and EKC was blocked by both naloxone and MR 2266. The non-opioid sedatives diazepam, phenobarbital and xylazine, administered in sedative doses, did not prevent apomorphine-induced emesis. Our results suggest that a delta-receptor is involved in the emetic effect and a mu- and/or or kappa-receptor in the antiemetic effect of opioids.

Animals↗
PubMed1983

Effects of antiemetics on the acquisition and recall of radiation- and lithium chloride-induced conditioned taste aversions.

A series of experiments were run to evaluate the effect of antiemetics on the acquisition and recall of a conditioned taste aversion induced by exposure to ionizing radiation or by injection of lithium chloride. Groups of male rats were exposed to 100 rad gamma radiation or 3 mEq/kg lithium chloride following consumption of a 10% sucrose solution. They were then injected with saline or with one of three antiemetics (prochlorperazine, trimethobenzamide, or cyclizine) at dose levels that have been reported to be effective in attenuating a previously acquired lithium chloride-induced taste aversion. The pretreatments with antiemetics had no effect on the acquisition or recall of either the lithium chloride- or radiation-induced taste aversion. The data suggest that antiemetics do not disrupt lithium chloride-induced taste aversions as previously reported, nor do they effect radiation-induced taste aversion learning.

Animals↗
PubMed1991

Comparison of ondansetron and ondansetron plus dexamethasone as antiemetic prophylaxis during cisplatin-containing chemotherapy.

Ondansetron, a serotonin antagonist, is effective in controlling the emesis associated with cancer chemotherapy; however, emesis in patients receiving high-dose cisplatin is poorly controlled by ondansetron alone. Dexamethasone is an effective antiemetic with no known interaction with serotonin receptors and was thus chosen for study in combination with ondansetron. 31 patients (30 male, 1 female; median age 28.5 years, range 18-49) receiving a 4-day course of a chemotherapy regimen containing cisplatin (100-120 mg/m2) for metastatic germ-cell tumours were entered in a randomised, double-blind, cross-over trial comparing oral ondansetron plus placebo with oral ondansetron plus dexamethasone as antiemetic prophylaxis. Ondansetron (8 mg every 8 h) was given to all patients for 8 days from the start of chemotherapy. Patients were given 8 mg of dexamethasone or placebo every 8 h starting 2 h before cisplatin (on day 4) and continuing for six doses (ie, for 2 days only). A second course of chemotherapy began 14 days after the start of the first, during which patients crossed over to the alternative antiemetic regimen. Results were available from 27 patients. In the 24-48 h after cisplatin 78% of patients taking ondansetron plus dexamethasone reported complete or major control of emesis compared with 30% of those taking ondansetron plus placebo (p = 0.001). Cross-over analysis showed a significant advantage for ondansetron plus dexamethasone in the control of nausea (p = 0.013) and emesis (p less than 0.001) over the 8-day study. 24 of 26 patients expressed a preference for the combination therapy (p less than 0.001). Ondansetron plus dexamethasone is effective antiemetic prophylaxis for high-dose cisplatin chemotherapy, has few side effects, and is active when given orally.

Administration, Oral↗
PubMed1989

Antiemetic therapy: management of chemotherapy-induced nausea and vomiting.

Physicians and nurses involved in the care of oncology patients share the responsibility for proper management of chemotherapy-induced nausea and vomiting. Oncology nurses have taken an active part in the research and investigation of new antiemetic agents and the sharing of this knowledge with others. Identifying patient characteristics, using specific guidelines for antiemetic selection, and a knowledge of the antiemetic agents that are active singly or in combination can mean the difference between success and failure in preventing or controlling vomiting induced by chemotherapy. Proper dosing and scheduling of antiemetics using recommendations that have proved efficacious can further decrease a patient's discomfort during a most difficult time in his or her life.

Antiemetics↗
PubMed1993

A randomised cross-over trial of antiemetic therapy for platinum-based chemotherapy. Improved control with an intensive multiagent regimen.

In a partially blinded randomised cross-over trial, 78 patients receiving cisplatinum based chemotherapy were assigned to receive two forms of antiemetic therapy: SAD, a regimen composed of serenace (haloperidol), ativan (lorazepam), and dexamethasone followed by low dose maxolon (metoclopramide) and STADMAX, a regimen composed of scopolamine (hyoscine), tavegyl (clemastine), ativan, dexamethasone and high dose maxolon. Each antiemetic regimen was given in random order, with the first and second cycles of cytotoxic chemotherapy. 66 (85%) patients completed both cycles of antiemetic therapy and were available for the cross-over comparison. Significantly less acute vomiting, as assessed by nurse observer (P < 0.0001), and less delayed vomiting, as assessed by patient diary (P = 0.03), were seen with STADMAX. In the first 18 h, complete control of vomiting (no episodes) was achieved in 30 (45%) patients with STADMAX compared with 10 (15%) receiving SAD. Overall, major control of emesis (< or = 2 episodes) was achieved in 56 (85%) patients with STADMAX compared with 35 (53%) receiving SAD. Vomiting was also better controlled on STADMAX in the week after this initial 18 hour period based on the 7 day patient diary with no vomiting episodes in 18/65 (28%) on STADMAX vs. 13/65 (20%) on SAD. However, no significant differences in appetite, nausea or vomiting were found when based on linear analogue self assessment (LASA) scales recorded by patients. Significant differences in side effects of the two antiemetic regimens were noted on LASA scales with more dry mouth (P = 0.01), blurred vision (P = 0.03) and diarrhoea (P = 0.04) associated with STADMAX and more restlessness (P = 0.002) associated with SAD. Significantly, no episodes of dystonic reactions were seen among patients on either regimen. In the 68 patients who completed both cycles and were in a position to express a preference, 46 (68%) preferred STADMAX compared with only 20 (29%) who preferred SAD (P = 0.001), while 2 patients expressed no preference. It is concluded that STADMAX is the preferred regimen to SAD for the control of cisplatinum-related emesis. It has a role, both where specific serotonin 3 antagonists are not available and as a model for building more effective combinations where these agents are available.

Adult↗
PubMed2004

Effects of antiemetic drugs on glucose 6-phosphate dehydrogenase and some antioxidant enzymes.

The aim of this study was to investigate effect of antiemetics on G6PD and antioxidant enzymes. Antiemetics are currently being used to reduce or prevent nausea and vomiting in patients. This is the first study to show effect of antiemetics on glucose-6-phosphate dehydrogenase (G6PD) and antioxidant enzyme activities. For in vitro studies, G6PD was purified from human erythrocyte, 10, 26-fold in a yield of 51.3% by using ammonium sulphate precipitation and 2',5'-ADP-Sepharose 4B affinity gel. The purified enzyme showed a single band on sodium dodecyl sulfate-polyacrilamide gel electrophoresis (SDS-PAGE). The effects of four different antiemetics (granisetron hydrochloride, ondansetron hydrochloride, metoclopramide hydrochloride, trimethobenzamide hydrochloride) were investigated on the purified enzyme. Granisetron hydrochloride and ondansetron hydrochloride inhibited the enzyme activity (Ki values; 5.05 mM and 0.034 mM, I50 values; 3.9 mM and 0.036 mM, respectively). Metoclopramide hydrochloride, trimethobenzamide hydrochloride showed no inhibition effects. In addition, in vivo studies, effects of ondansetron hydrochloride on the G6PD, glutathione reductase (GR), glutathione peroxidase (GPx) and catalase (CAT) were examined in the rat erythrocytes. G6PD (49% of control), GR (55% of control), CAT (60% of control) activities in erythrocytes were significantly decreased whereas GPx (183% of control) was significantly increased. A marked alteration in these enzymes may be result of oxidative stress in the rats receiving ondansetron hydrochloride.

Animals↗
PubMed2000

Economics and health-related quality of life in antiemetic therapy: recommendations for trial design.

Emesis (nausea and vomiting) is one of the most important toxicities associated with chemotherapy. Although it is not life threatening, it has a major impact on a patient's health-related quality of life (HRQL) and overall response to chemotherapy. New antiemetics are expensive and well-conducted comparative health economic studies are rare. The aim of the study was to review the literature in the area of chemotherapy-induced emesis in cancer patients and to offer recommendations for the inclusion of these outcomes in the design of clinical trials for new antiemetic therapies. The economic literature was reviewed based on methodological standards for economic evaluation. Many studies did not comply with standards, specifically with regard to the choice of alternatives, chosen perspective, setting, type of emesis, measurement of costs and defining outcomes (including health-related quality of life). These issues are described for each study and recommendations for trial design are presented. The role of economic data is to support decision making in choosing between competing antiemetic therapies. It is the combination of clinical outcomes, costs and health-related quality of life, which will allow treating physicians to comprehensively assess the relative value of antiemetic therapies and to provide the most cost-effective therapy for their patients.

Antiemetics↗
PubMed1997

An all oral antiemetic regimen for patients undergoing high-dose chemotherapy with peripheral blood stem cell transplant.

The purpose of the study was to assess the toxicity and efficacy of an oral, combination antiemetic regimen including granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA, USA) in the setting of highly emetogenic conditioning chemotherapy for stem cell transplantation. Antiemetic prophylaxis consisted of oral granisetron 2 mg once daily, oral prochlorperazine 10 mg q 6 h and oral dexamethasone 4 mg q 6 h, beginning 1 h prior to chemotherapy on each of the 4 days of chemotherapy and continuing until 24 h after the completion of high-dose chemotherapy (HDC). Patients received either CVP (cyclophosphamide 6 g/m2, VP-16 1800 mg/m2 and carboplatin 1200 mg/m2) or CTP (thiotepa 500 mg/m2 in place of VP-16) in four daily doses given over 4 h from days -4 to -1. Previously mobilized and cryopreserved peripheral blood stem cells (PBSC) were reinfused on day +1. Evaluation of nausea, emetic episodes (EE), adverse events, and rescue medications were recorded on a daily patient diary. Thirty-six patients were entered. Fifty-three percent (95% CI = 37-75%) of patients achieved complete response for emesis (CR = 0 EE/24 h) and 75% (95% CI = 58-90%) had combined complete and major response (CR+MR = 0-3 EE/24 h) during all 5 of the treatment days. During the 5 study days, the average number of patient-days with no emesis was 3.7 (74%) and with 1-3 EE was 4.3 (86%). On days -4, -3, -2, -1 and 0, the combined CR+MR rate for emesis was 97, 92, 86, 78 and 75%, respectively. Nausea was absent or mild on all 5 study days in 57% (95% CI = 37-75%). Eight patients had severe late-onset emesis occurring on days +1 to +3 after reinfusion of stem cells. No clinically significant toxicities attributable to the antiemetic regimen were observed. An all oral antiemetic regimen of granisetron, prochlorperazine and dexamethasone appears to be safe and highly effective in patients receiving multiple, daily, high-dose chemotherapy regimens. This regimen offers the advantage of cost-savings, a low side-effect profile and ease of administration in the predominately outpatient setting of HDC with peripheral blood stem cell transplant (PBSCT).

Administration, Oral↗
PubMed2002

Outcomes of antiemetic prophylaxis in children undergoing bone marrow transplantation.

A prospective survey of the control of acute and delayed antineoplastic and radiation-induced nausea and vomiting was undertaken in children undergoing bone marrow transplantation (BMT) at The Hospital for Sick Children. Prior administration of antineoplastic agents or irradiation, presence of anticipatory nausea or vomiting prior to starting the conditioning regimen, antiemetic use within 24 h of conditioning, the prescribed antineoplastic and/or radiation ablative regimen, and prescribed antiemetic regimens were recorded. Emetic episodes, dietary intake, administration of conditioning agents and antiemetics, and adverse effects were monitored on each day of the conditioning regimen and for 96 h thereafter. Children older than 3 years of age assessed their nausea on each study day. Twenty-five children were followed for 258 patient days. Children did not vomit or retch on 73% and 43% of patient days, in the acute and delayed phases, respectively. Nausea data were evaluable for 21 children on 200 patient days. Nausea was absent on 55% and 26% of patient days in the acute and delayed phases, respectively. Five children never had an emetic episode during the entire study period. One child was completely free from nausea and vomiting throughout the study period. Antineoplastic and radiation-induced nausea and vomiting can be successfully prevented in the majority of children undergoing BMT. However, effective treatment strategies must be developed in the event of antiemetic failure and for effective prophylaxis in children who cannot tolerate dexamethasone.

Adolescent↗
PubMed1991

[Comparison of the antiemetic effectiveness of granisetron and alizapride plus dexamethasone in cytostatic therapy].

In a randomized single-blind international multicentre trial, two antiemetic regimens were compared in 115 oncology patients undergoing chemotherapy for the first time (cisplatin greater than 15 mg/m2, or ifosfamide greater than 1200 mg/m2 or etoposide greater than 120 mg/m2). One group received granisetron, a 5-hydroxytryptamine type-3-receptor antagonist, 40 micrograms/kg alone intravenously before chemotherapy, with, if necessary, up to two further doses daily of 40 micrograms/kg. The second group received a combination of alizapride plus dexamethasone (4 mg/kg alizapride and 8 mg/kg dexamethasone before chemotherapy, repeated, if necessary, after 4 and 8 hours up to two additional doses). There was good antiemetic efficacy (a maximum of one episode of vomiting in 24 hours = "major efficacy") in 50 of 62 patients (80.7%) in the granisetron group, and in 37 out of 53 (69.8%) of those treated with alizapride and dexamethasone; failure of antiemetic therapy occurred in 4.8% (granisetron) and 15.1% (combination) of patients. For the first day of each 5-day chemotherapy cycle, there was a higher rate of excellent antiemetic efficacy (no or only mild nausea, and no vomiting) with granisetron (90.3% vs 69.8%, P less than 0.006). The frequency (29% vs 32%) and nature of side effects (obstipation, diarrhoea, headaches, anxiety, vertigo), the causes of which were not differentiated, were similar. No extrapyramidal reactions occurred with granisetron. Of the 62 patients treated with granisetron, 47 did not require any further granisetron after the single daily prophylactic dose.

Adult↗
PubMed1998

Outcomes of antiemetic therapy after the administration of high-dose antineoplastic agents.

Patterns of antiemetic therapy and its outcomes in patients undergoing high-dose antineoplastic therapy were studied. The study, conducted at a cancer center, included both a retrospective evaluation of patients undergoing highly emetogenic high-dose chemotherapy with peripheral blood stem-cell rescue between November 1994 and December 1995 and a concurrent evaluation of patients treated between January and May 1996. During the study period the recommended antiemetic regimen for highly emetogenic chemotherapy was a single dose of granisetron 1 mg i.v. daily 30 minutes before treatment on days of chemotherapy. Severity of nausea and vomiting during both the acute phase (from day 1 of chemotherapy to 24 hours after its completion) and delayed phase (from 24 hours to five days after the end of chemotherapy) was graded according to the Common Toxicity Criteria Grading Scale. A total of 59 patients were evaluable; 41 were reviewed retrospectively, and 18 were reviewed concurrently. On day 1 of the acute phase, 53 patients (90%) had no vomiting and 51 patients (86%) had no nausea. The frequency and severity of nausea and vomiting increased on successive acute-phase days, and it was necessary to add other antiemetics. Nausea and vomiting continued to be significant problems throughout the delayed phase; 32 (54%) of the patients had a maximum of grade 3 nausea, and 29 patients (49%) had a maximum of grade 2 vomiting. Substantial numbers of patients who received selective serotonin type 3 receptor antagonists before high-dose antineoplastic agents had significant nausea and vomiting that required the addition of other antiemetics.

Adult↗
PubMed1993

Tropisetron in the prevention of chemotherapy-induced nausea and vomiting in patients responding poorly to previous conventional antiemetic therapy.

An open, two-armed, multicentre trial was conducted in 231 patients with malignant disease who had previously failed to respond to conventional antiemetic treatment for the prevention of chemotherapy-induced nausea and vomiting. Patients were randomized to receive either tropisetron (5 mg/day; n = 115) or a standard antiemetic therapy, which was considered optimal for each individual but did not include a 5-HT3 receptor antagonist (n = 116). Acute vomiting on Day 1 was controlled in 60 (52%) tropisetron patients, compared with only 29 (25%) patients receiving optimal standard therapy (p < 0.001). Acute nausea was completely inhibited in 37 (32%) tropisetron patients, compared with 22 (19%) patients on optimal standard therapy (p < 0.05). On Day 1, delayed vomiting was also significantly better prevented by tropisetron (p < 0.001). Side effects from tropisetron (headache and constipation) were mild, and no extrapyramidal symptoms were observed in any tropisetron patients, in contrast, to 14 (13%) patients in the 'optimal standard' group. In conclusion, in cases of acute nausea and vomiting it is more effective to switch refractory patients to tropisetron rather than attempt to optimize the dose of standard antiemetic therapy. For delayed nausea and vomiting, combination antiemetic therapy, with differing types of receptor antagonism and corticosteroids may provide the best way forward. Such studies are in progress.

Antiemetics↗
PubMed1996

Antiemetic effect of subhypnotic doses of propofol after thyroidectomy.

Postoperative nausea and vomiting (PONV) are unpleasant, often underestimated side effects of anaesthesia and surgery, not devoid of medical complications. Prevention with antiemetics is only partially effective. Propofol has been shown recently to possess antiemetic properties in several situations. In this prospective, randomized, controlled trial, we have compared the antiemetic efficacy of subhypnotic doses of propofol, with Intralipid as placebo, after thyroidectomy. We studied 64 patients of both sexes, aged 22-71 yr, ASA I or II, undergoing thyroidectomy. After premedication with a benzodiazepine, balanced anaesthesia was produced with isoflurane and nitrous oxide in oxygen, and supplementary analgesia with fentanyl i.v. as required. Postoperative analgesia was provided with non-opioids, and piritramide 0.25 mg kg-1 i.m. on demand. Patients were allocated randomly and blindly to receive a 20-h infusion of either propofol or 10% Intralipid 0.1 ml kg-1 h-1. Intralipid, the excipient of propofol, was chosen as placebo as it is devoid of antiemetic effects. Sedation scores, respiratory and cardiovascular variables, and incidence of PONV were assessed every 4 h for 24 h. Pulse oximetry and ECG were monitored continuously. Both groups were comparable in characteristics, surgical and anaesthesia procedures, amount of opioids given during and after operation, and total amount of the study drug infused after operation. Occurrence of PONV was similar before the start (propofol 41%, Intralipid 50%) and after completion (propofol 0.64%, Intralipid 1.6%) of infusion and decreased with time in both groups during the infusion. However, symptoms were reduced to nil with propofol but persisted and were more severe with Intralipid during infusion (P < or = 0.01). The overall incidence of PONV during infusion was 10% (three of 32 patients) in the propofol group and 65% (21 of 32 patients) in the Intralipid group. Cardiovascular and respiratory variables, and SpO2 were unaltered, and sedation decreased similarly with time in both groups. We conclude that propofol, given at subhypnotic doses, effectively reduced the incidence of PONV without untoward sedative or cardiovascular effects.

Adult↗
PubMed1991

Serotonin antagonists: a new class of antiemetic agents.

Despite a number of significant advances over the past decade, prevention and treatment of chemotherapy-induced emesis remain formidable problems, particularly with cisplatin-containing regimens. Nearly one third of patients receiving high-dose cisplatin still experience substantial emesis despite the best available conventional antiemetics, and the toxic effects of these agents remain quite troublesome. In recent years, a new class of agents, the serotonin antagonists, has been identified. These agents hold promise for clinical utility in a wide range of areas. Selective antagonists of the serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor have proven in early clinical trials to be potent antiemetic agents in patients receiving cytotoxic chemotherapy, with efficacy comparable to or superior to that of conventional antiemetics. Toxic effects to date with the 5-HT3 receptor antagonists have been modest. The current state of knowledge with respect to these agents as antiemetics for patients receiving cytotoxic chemotherapy is summarized.

Antiemetics↗
PubMed1996

A comparison of costs and efficacy of ondansetron and droperidol as prophylactic antiemetic therapy for elective outpatient gynecologic procedures.

Ondansetron and droperidol are both effective prophylactic antiemetics for gynecologic outpatient procedures. However, increased drowsiness, delayed discharge, and postdischarge restlessness may occur with droperidol, and ondansetron is costly. In this prospective, randomized, double-blind, placebo-controlled study involving 161 women, we compared the efficacy, safety, and cost-effectiveness of ondansetron (4 mg intravenously [i.v.] with droperidol (0.65 mg or 1.25 mg i.v.) in the prevention of postoperative nausea and vomiting (PONV) after outpatient gynecologic surgery. The incidence of PONV, times to achieving preset recovery criteria, and patient-evaluated visual analog scales for sedation, anxiety, pain, and nausea were recorded, along with postdischarge emetic episodes, medications, quality of sleep, and time to resumption of food intake, normal activity, and return to work. A decision analysis tree was used to divide each data set into nine mutually exclusive subgroups, and costs and probabilities were assigned to each subgroup. The cost-effectiveness ratio was determined by summing these weighted costs and dividing by the number of patients free from both PONV and side effects of antiemetic therapy. The incidence of PONV in the hospital and after discharge, the need for rescue antiemetic therapy, and recovery and discharge times were similar for the ondansetron and both droperidol groups but differed significantly from those for the placebo group. The cost-effectiveness ratios for both droperidol 0.65 mg and 1.25 mg groups were significantly lower than those for the ondansetron and placebo groups. We conclude that droperidol 0.625 mg i.v. provides antiemetic prophylaxis comparable to that of ondansetron 4 mg i.v. without increasing side effects or delaying discharge and is most cost-effective.

Activities of Daily Living↗