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Tropisetron in the prevention of postoperative nausea and vomiting.

STUDY OBJECTIVES: To evaluate the efficacy of tropisetron, a selective 5-HT(3) receptor antagonist, in preventing nausea and vomiting in high-risk inpatients undergoing various surgical procedures. DESIGN: Prospective, open, nonrandomized, observational, interventional study. SETTING: Postanesthesia care unit, and surgical wards of the University Hospital Center, Charleroi. PATIENTS: A total of 1,132 elective surgical inpatients (>15 years of age) in two separate surveys. The first prospective survey covered all surgical adult inpatients (n = 671) after various surgical procedures over a 3-month period. A new 3-month survey was performed to assess the effectiveness of the preventive measure and included another 461 patients. INTERVENTIONS: Risk factors associated with nausea and vomiting were recorded in the first survey and used to establish an antiemetic policy. This consisted in the administration of tropisetron 2 mg intravenously after anesthesia induction, if two patient-related risk factors associated with high-risk surgery and general anesthesia were present. MEASUREMENTS AND MAIN RESULTS: Nausea frequency and intensity, assessed every 4 hours using a visual analog scale (VAS), frequency and times of vomiting episodes and the need for rescue medication were recorded for 72 hours postoperatively. Nausea was experienced by 18.8% and vomiting by 9.8% of the patients in the first survey (211 high risk-patients of 671). In the second survey, 137 patients of 461, considered at high-risk received prophylactic tropisetron. The proportion of patients having nausea decreased to 11.1% (p,178 0.01) and vomiting episodes to 2.8% (p < 0.001). Twenty-six of the tropisetron-treated patients (19%) suffered subsequent postoperative nausea and vomiting (PONV). Patient satisfaction with tropisetron was high. CONCLUSION: Prophylactic tropisetron can reduce the incidence of PONV in selected high-risk inpatients undergoing various types of surgical procedures.

Adult↗

Prophylactic ondansetron is effective in the treatment of nausea and vomiting but not on pruritus after cesarean delivery with intrathecal sufentanil-morphine.

STUDY OBJECTIVES: To assess the safety and efficacy of ondansetron for prevention of pruritus, nausea and vomiting after cesarean delivery with intrathecal sufentanil-morphine. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Referral center, institutional practice. PATIENTS: 100 nonbreastfeeding women undergoing elective cesarean delivery with sufentanil-morphine-bupivacaine anesthesia. INTERVENTIONS: After the umbilical cord was clamped, patients in Group 1 received ondansetron 8 mg intravenously (IV) and patients in Group 2 received placebo. MEASUREMENTS: Frequency and severity of postoperative (24-hour) pruritus, nausea and vomiting, surgical pain, and side effects related to ondansetron were recorded. MAIN RESULTS: In the ondansetron group, 38 patients had pruritus (16 mild and 22 severe) and 9 patients had nausea and vomiting (5 mild and 4 severe). In the placebo group, 41 patients had pruritus (21 mild and 20 severe) and 29 patients had nausea and vomiting (9 mild and 15 severe). The frequency and severity of the nausea and vomiting episodes were significantly reduced in the ondansetron group. Pain scores were comparable between groups. No side effects related to ondansetron were reported. CONCLUSIONS: Prophylactic IV ondansetron 8 mg is safe and effective in reducing the frequency and the severity of nausea and vomiting, but not pruritus, following cesarean delivery with intrathecal sufentanil-morphine.

Adult↗

Propofol-ketamine versus propofol-fentanyl for outpatient laparoscopy: comparison of postoperative nausea, emesis, analgesia, and recovery.

STUDY OBJECTIVE: To compare postoperative nausea, emesis, analgesia, and recovery between propofol-ketamine and propofol-fentanyl in outpatient laparoscopic tubal ligations with general anesthesia. STUDY DESIGN: Prospective, randomized, blinded study. SETTING: Tertiary-care women's hospital. PATIENTS: 120 ASA physical status I and II ambulatory patients scheduled for elective laparoscopic tubal ligation. INTERVENTIONS: Patients were randomized to two groups to receive either ketamine (1-1.5 mg/kg) or fentanyl (3-5 microg/kg). MEASUREMENTS: Measured variables included total dose of ketamine, fentanyl, propofol, and operating time. Vital signs, pain visual analog scale scores (VAS), nausea VAS, presence of emesis, treatment for nausea and vomiting, pruritus, sedation, and presence of dreaming were recorded on postanesthesia care unit (PACU) admission, PACU discharge, stepdown unit admission, and hospital discharge. Results are expressed as means +/- SD or medians and analyzed using t-test, Chi-square, or Mann-Whitney (p < 0.05). MAIN RESULTS: No differences were noted with respect to propofol dose, operating times, pain or nausea VAS scores, emesis, treatment for nausea and vomiting, pruritus, and sedation on PACU admission, PACU discharge, stepdown unit admission, and hospital discharge. The ketamine group had a higher heart rate, required more pain medication, and had a higher frequency of dreaming on PACU admission than the fentanyl group. These differences became insignificant on PACU discharge. CONCLUSIONS: For outpatient laparoscopic tubal ligations with general anesthesia, propofol-ketamine does not improve postoperative nausea, emesis, analgesia or recovery compared with the propofol-fentanyl combination.

Adult↗

An alternative method to alleviate postoperative nausea and vomiting in children.

STUDY OBJECTIVE: To evaluate whether isopropyl alcohol vapor is an effective treatment for postoperative nausea and vomiting. DESIGN: Double-blind, randomized, controlled study. SETTING: Pediatric surgery center. PATIENTS: 91 ASA physical status I and II children age 6-16 years, scheduled to undergo general anesthesia and elective outpatient surgery. INTERVENTIONS: Subjects were randomized to inhale isopropyl alcohol or saline. The intervention was repeated up to three times. If postoperative nausea or vomiting persisted after three sequences, intravenous ondansetron was administered as rescue therapy. MEASUREMENTS AND MAIN RESULTS: Improvement in nausea was assessed using a visual analog scale, and improvement in vomiting was assessed using categorical analysis. After three treatment sequences, 65% of the children in the treatment group and 26% of the children in the control group had a significant reduction in the severity of either nausea or vomiting (p = 0.03). However, 54% of subjects in the treatment group and 80% of subjects in the control group had recurrent nausea or vomiting within 20 to 60 minutes. CONCLUSIONS: Under the conditions of this study, repetitive inhaled isopropyl alcohol only achieved a transient antiemetic effect in children with established postoperative nausea or vomiting following general anesthesia and surgery.

2-Propanol↗

Haloperidol vs. ondansetron for the prevention of postoperative nausea and vomiting following gynaecological surgery.

BACKGROUND AND OBJECTIVE: Ondansetron is widely used for the prophylaxis of postoperative nausea and vomiting, while haloperidol is an antiemetic that lacks recent data on efficacy and adverse effects. METHODS: In this prospective, randomized, double-blinded study involving 93 females undergoing gynaecological procedures under general anaesthesia, we compared the efficacy and adverse effects of prophylactic haloperidol 1 mg intravenous and ondansetron 4 mg intravenous vs. placebo. RESULTS: During the overall observation period (0-24 h), in the haloperidol, ondansetron and placebo groups respectively, the incidence of nausea and/or vomiting was 40.7% (11/27), 48.2% (13/27) and 55.5% (15/27), and the need of rescue antiemetics was 22.2% (6/27), 44.4% (12/27) and 40.7% (11/27), with P values >0.05 among the three groups. During the early observation period (0-2 h), in the haloperidol, ondansetron and placebo groups respectively, the incidence of nausea and/or vomiting was 13.7% (4/29), 26.6% (8/30) and 43% (13/30), and the need for rescue antiemetics was 6.8% (2/29), 26.6% (8/30) and 36.6% (11/30). Between haloperidol and placebo groups, the P value was 0.04 for nausea and/or vomiting, and was 0.01 for rescue antiemetics, in addition to lower nausea scores (P = 0.03). During the late observation period (2-24 h), no significant difference was shown among the three groups. CONCLUSION: The prophylactic administration of 1 mg intravenous haloperidol or 4 mg ondansetron, in female patients undergoing gynaecological surgery, did not improve the overall incidence of nausea and/or vomiting vs. placebo. However, haloperidol 1 mg proved to be an effective antiemetic in the early observation period without significant adverse effects.

Adult↗

Anticipatory nausea and emesis, and psychological morbidity: assessment of prevalence among out-patients on mild to moderate chemotherapy regimens.

The prevalence of nausea and emesis among a series of out-patients (n = 95) receiving mainly mild-to moderately-emetic cytotoxics, was assessed, along with levels of psychological morbidity. Particular focus was given to the rates of psychologically-based (anticipatory) nausea and emesis. Results indicated that 23% of patients experienced anticipatory nausea and the majority reported that this occurred before at least half of the previous treatment cycles. Both emetic challenge of chemotherapy regimen and younger age were linked to this anticipatory effect. The data clearly indicated that nausea and emesis, both post-treatment and in anticipation of treatment, carried a psychological cost with anxiety being highest in those experiencing anticipatory nausea and/or emesis. The role of anxiety in the aetiology of psychologically-based nausea and emesis was not evaluated and it is considered that a prospective study is needed to clarify the exact contribution of psychological factors in the incidence of both post-treatment and anticipatory side-effects.

Adult↗

An audit of post-operative nausea and vomiting, following cardiac surgery: scope of the problem.

Post-operative nausea and vomiting is a major problem for patients following cardiac surgery. The literature in this area identifies that there are a number of individual patient and post-operative factors which increase the risk of post-operative nausea and vomiting, including female gender, non-smoker, age, use of opioids, pain and anxiety. An audit involving 200 patients, who had undergone cardiac surgery was implemented to assess/evaluate the incidence of nausea and vomiting for this patient group. Data collected included information relating to nausea and vomiting, pain, consumption of morphine and other individual patient variables. The results suggest that nausea and vomiting, is experienced by a large number of patients after cardiac surgery (67%), with the majority suffering on the first day after surgery. The duration of nausea and vomiting for most is short, but for a significant number (7%) it can last up to one-quarter of their initial post-operative course. The paper discusses key implications for practice arising from this project.

Adult↗

Cost-effectiveness of ondansetron for postoperative nausea and vomiting.

The decision as to whether prophylaxis against postoperative nausea and vomiting is better than treatment of established postoperative nausea and vomiting could be made on the basis of cost-effectiveness. The cost-effectiveness of ondansetron was calculated using data from published quantitative systematic reviews of randomised trials. Milligrams of ondansetron required to achieve a desired endpoint were chosen as a cost unit. Modelling was based on a cohort of 1000 patients, and examined control event rates (i.e. incidence of postoperative nausea and vomiting without prophylaxis) of between 10 and 90%. In a sensitivity analysis, cost-effectiveness of recommended intravenous doses (4 mg for treatment and prophylaxis) was compared with minimal effective doses as shown by meta-analysis (1 mg for treatment, 8 mg for prophylaxis). Fewer patients experience any postoperative nausea and vomiting symptoms with prophylaxis compared with treatment. But prophylaxis is only marginally more effective than treatment, and treatment of established postoperative nausea and vomiting with effective doses (i.e. 1 or 4 mg) is more cost-effective and safer than prophylaxis with effective doses (i.e. 4 or 8 mg). Reasons for this are the selective treatment of patients who actually need treatment, the high success rate with a lowest dose tested (1 mg) in established postoperative nausea and vomiting, and the disappointing antinausea effect of prophylactic ondansetron even at an eight-fold higher dose.

Antiemetics↗

Comparison of the neurokinin-1 antagonist GR205171, alone and in combination with the 5-HT3 antagonist ondansetron, hyoscine and placebo in the prevention of motion-induced nausea in man.

AIMS: In man a neurokinin-1 (NK1) receptor antagonist has previously been shown to be ineffective in the prevention of motion-induced nausea. The antiemetic efficacy of NK1 receptor antagonists against chemotherapy-induced emesis is, however, enhanced when combined with a 5-HT3 receptor antagonist. Hence the efficacy of the NK1 antagonist GR205171 in combination with the 5-HT3 antagonist ondansetron (Zofrantrade mark) was assessed in motion-induced nausea. METHODS: GR205171 25 mg i.v., with and without concomitant administration of ondansetron 8 mg i.v., and hyoscine hydrobromide 0. 6 mg orally (positive control) were compared with placebo in a model of motion-induced nausea. The study was performed to a four-period, randomized, balanced, double-blind, crossover design in 16 healthy subjects. The end-point was the exposure to the motion stimulus required to produce moderate nausea in the subjects. RESULTS: The motion stimulus required to produce moderate nausea was significantly greater for the positive control than placebo (P < 0. 001). There was no significant difference between either GR205171 or GR205171 plus ondansetron and placebo (P = 0.648 and 0.342, respectively). CONCLUSIONS: The enhancement of NK1 receptor antagonist antiemetic activity through combination with a 5-HT3 receptor antagonist is not replicated in motion-induced nausea.

Adolescent↗

Droperidol-supplemented anaesthesia decreases post-operative nausea and vomiting but impairs post-operative mood and well-being.

Post-operative nausea and vomiting is distressing for patients and can cause dissatisfaction and impaired well-being in the post-operative period. This study examined the question whether the reduced incidence of post-operative nausea and vomiting inevitably translates into improved clinical status and well-being. In this context high doses of droperidol were investigated. On the one hand, droperidol is known to be a powerful anti-emetic, but on the other hand there is concern about psychological effects, both in the pre- and the post-operative period. In this prospective randomized double-blinded study, droperidol (5-7.5 mg) was compared with midazolam (5-7.5 mg) used to supplement fentanyl-N2O based anaesthesia, with respect to post-operative mood and well-being using a psychological questionnaire (Bf-S-test). Furthermore, the incidence of post-operative nausea and vomiting was recorded. Out of 160 patients undergoing thyroidectomy and laparoscopic cholecystectomy, data from 150 patients were analysed. The administration of droperidol significantly lowered the incidence of post-operative nausea and vomiting from 77.8% to 55.1% compared with midazolam (P = 0.0059; chi 2-test). Although post-operative nausea and vomiting is an independent risk factor for post-operative discomfort and bad mood, patients receiving droperidol showed impaired well-being 6 h after surgery. Well-being scores returned to pre-operative base-line values and did not differ between the two groups 24 and 48 h post-operatively. The reduced incidence of post-operative nausea and vomiting achieved with high dose droperidol does not equate with increased post-operative well-being. It is an important point at issue to decide whether smaller doses of droperidol that are commonly used for anti-emetic therapy are free of these side effects.

Adjuvants, Anesthesia↗

Postoperative nausea and vomiting after breast surgery: efficacy of prophylactic ondansetron and droperidol in a randomized placebo-controlled study.

Postoperative nausea and vomiting (PONV) is a common adverse phenomenon following breast surgery. The efficacy of ondansetron and droperidol in preventing post-operative nausea and vomiting in women undergoing breast surgery was compared in this randomized, double-blind, placebo-controlled study. Altogether 207 women were randomly assigned to receive either a single intravenous dose of droperidol (1.25 mg) (n = 69), ondansetron (8 mg) (n = 67) or saline (n = 71) immediately after induction of general anaesthesia with thiopental, fentanyl, atracurium, nitrous oxide in oxygen and isoflurane. Complaints of nausea, vomiting and requests for rescue antiemetics were recorded during a 24-h period postoperatively. During the initial 2 h in the postanaesthesia care unit, the incidence of postoperative nausea and vomiting was 15%, 6% and 12% in the placebo, droperidol and ondansetron groups, respectively (NS). The incidence of post-operative nausea and vomiting during the first 24 h was 61%, 48% and 45% in the placebo, droperidol and ondansetron treatment groups, respectively (NS). Postoperative analgesic requirements and the length of stay in the post-anaesthesia care unit were equal in all three treatment groups. It is concluded that the intravenous pretreatment with single doses of ondansetron or droperidol did not substantially prevent postoperative nausea and vomiting after breast surgery.

Adolescent↗

A pilot study of the use of progressive muscle relaxation training in the management of post-chemotherapy nausea and vomiting.

The aim of this pilot study was to assess the effectiveness of using progressive muscle relaxation training (PMRT) in the management of chemotherapy-related nausea and vomiting in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide as well as feasibility issues for a larger study. Eight patients were randomly assigned to receive either oral anti-emetics as per hospital protocol (maxolon) or adjuvant PMRT. Both groups, however, received intravenous anti-emetics half an hour before the chemotherapy administration. PMRT was given by a trained nurse once a day for 5 days. A repeated measures design was used. Nausea and vomiting were assessed with the Morrow Nausea and Vomiting Scale. Results indicated that the duration and intensity of nausea were lower in the experimental group, although the former was at a borderline level of significance. The duration and intensity of vomiting were also lower in the experimental group. Delayed nausea and vomiting was observed in both groups. Despite the small sample size, the study showed that PMRT is an effective adjuvant method to decrease nausea and vomiting in chemotherapy patients. This has implications for nursing practice, as it is a low-cost and easy-to-leam technique that can be incorporated in the care planning of patients receiving chemotherapy.

Adult↗

Slowing the titration rate of tramadol HCl reduces the incidence of discontinuation due to nausea and/or vomiting: a double-blind randomized trial.

BACKGROUND: Ultram [tramadol hydrochloride (HCl)] is a centrally acting analgesic that is widely prescribed for the treatment of moderate to moderately severe chronic pain. Although tramadol is generally well tolerated, some patients discontinue use early in the course of treatment because of nausea and vomiting. OBJECTIVE: To investigate the effect of three initial titration rates of tramadol HCl on the incidence of discontinuation due to nausea and/or vomiting in patients who previously did not tolerate tramadol HCl. METHOD: A multicentre, outpatient, randomized double-blind study was conducted, comprised of two phases: a 14-day open-label run-in phase and a 28-day double-blind phase. In the run-in phase the dose of tramadol was titrated over 4 days to the target of 200 mg/day. Patients who discontinued tramadol HCl due to nausea and/or vomiting in the open-label phase were eligible to enter the 28-day double-blind phase after a 10-day wash-out. Patients were randomized to one of three groups using a 10-, 16- or a 13-day titration schedule in order to achieve a target dosage of either 200 mg/day (10- and 16-day titration groups) or 150 mg/day (13-day titration group). The number of discontinuations due to nausea and/or vomiting in each group were compared. RESULTS: Significantly fewer patients (22%) discontinued because of nausea and/or vomiting in the 13- and 16-day titration groups compared to the 10-day group (P=0.008 and P=0.006, respectively). The time to discontinuation was also significantly delayed in the 13- and 16-day groups compared to the 10-day group (P=0.006 and P=0.007, respectively). The outcome of the 13-day titration to 150 mg/day was essentially the same as that of the 16-day titration to 200 mg/day, suggesting that this is a true rate effect rather than being dose related. CONCLUSION: This study demonstrated that a slower titration rate of tramadol HCl improves tolerability in patients who previously discontinued therapy due to nausea and/or vomiting. This study also demonstrates that the rate of titration of tramadol HCl rather than the target dose is the major determinant of tolerability.

Adult↗

Impact of an antiemetic protocol on postoperative nausea and vomiting in children.

The objective of the study was to demonstrate a decreased incidence of postoperative nausea and vomiting (PONV) in children through the use of an antiemetic protocol. PONV was recorded in children (1.5-15 years) after inpatient surgery under general anaesthesia in a prospective, interview based survey. Group 1 consisted of children having surgery 1 month before the introduction of a formalized antiemetic protocol and group 2, 2 months after its introduction. Data were collected over a 1-month period in each group. Outcome measures of nausea, emesis, antiemetic requirement and patient satisfaction were monitored for the first 24-h postoperative period. There were 272 children enrolled: 138 in group 1 and 134 in group 2. There was a difference between the two groups for gender (P=0.03), type of surgery (P=0.017), perioperative opioid (P=0.003) and perioperative antiemetic use (P=0.024). However, multivariate analysis did not demonstrate an impact on outcome from these factors. The incidence of postoperative nausea (PON) and postoperative vomiting (POV) following the introduction of the protocol was 36% and 34%, respectively. Moderate to severe nausea was decreased after introduction of the protocol (18% versus 9%, P=0.028) but moderate to severe vomiting failed to reach significance (19% versus 11%, P=0.078). The proportion of children who had repeated nausea decreased after the introduction of the protocol (17% versus 8%, P=0.02) but repeated episodes of vomiting remained unchanged (19% versus 14%). This was attributed to a significant increase in antiemetic prescribing by protocol in group 2 (10% versus 59%, P < 0.001). Patient satisfaction was high in both groups (85% versus 90%). The introduction of a postoperative antiemetic protocol improved prescribing frequency. This resulted in a decreased incidence of moderate to severe PON and a reduction in the number of patients with repeated nausea.

Adolescent↗

Low incidence of nausea and vomiting with intravenous opiate analgesia in the ED.

Two double-blind, placebo-controlled, prospective randomized trials in the emergency department (ED) setting have examined the use of metoclopramide for the prevention of opiate-induced nausea and vomiting. Both showed a low incidence of vomiting in the control group. This prospective observational study in 205 unselected ED patients with acute pain syndromes measured nausea and vomiting before intravenous opiate administration and 30 and 60 minutes posttreatment. Cumulative incidence of vomiting was 1.5% at 30 minutes and 2.4% at 60 minutes. Corresponding figures for nausea were 4.9% at 30 minutes and 9.3% at 60 minutes, with more than 75% of patients rating their nausea as mild. Prevalence of both nausea and vomiting were higher at baseline than after analgesia. These data support the findings of previous randomized trials that the incidence of nausea and vomiting after intravenous opiate analgesia in the ED is low and argues against routine use of prophylactic antiemetic administration in combination with opiate analgesia.

Adolescent↗

Behavioral treatment for the anticipatory nausea and vomiting induced by cancer chemotherapy.

The nausea and vomiting experienced by one in four cancer patients in anticipation of chemotherapy is probably a learned response to treatment. To determine whether behavioral approaches for altering learned responses might be useful treatments for these symptoms, we compared the effects of "systematic desensitization" (a behavioral treatment in which relaxation is learned as a response to situations in which patients have had anticipatory nausea and vomiting) with those of counseling and of no treatment. Sixty ambulatory cancer patients with anticipatory nausea and vomiting before their third and fourth chemotherapy treatments were randomized equally to the three groups. Significantly more patients receiving desensitization reported no anticipatory nausea before their fifth and sixth chemotherapy treatments than patients given counseling (P less than 0.05) or no treatment (P less than 0.01). Desensitized patients also reported significantly less severe anticipatory nausea (P less than 0.01) and vomiting (P less than 0.05) and a shorter duration of anticipatory nausea (P less than 0.01). We conclude that systematic desensitization appears to have an antiemetic effect in cancer patients who receive chemotherapy, and may be useful in the management of these problems.

Adult↗

Efficacy and tolerability of tropisetron in the prevention of cisplatin-induced nausea and vomiting in advanced non-small cell lung cancer.

The efficacy and tolerability of tropisetron were studied in an open trial comprising a total of 30 patients with advanced non-small cell lung cancer undergoing high-dose, cisplatin-based chemotherapy (cisplatin dosage 100 mg/m2). Patients received tropisetron 5 mg intravenous infusions for 15 min on day 1. followed by 5 mg tropisetron taken orally in the morning on days 2 6. All treated patients were assessed during the entire treatment period (6 days). Acute nausea and vomiting were evaluated during the 24 h after chemotherapy. Delayed nausea and vomiting were evaluated during days 2-6 after chemotherapy. Response to tropisetron was graded as: complete control, major control, minor control and failure for nausea or vomiting. Rates for complete plus major control of acute nausea and vomiting in cycles 1-5 were 77%, 81%, 86%, 67% and 75%, respectively. Rates for complete plus major control of delayed nausea and vomiting in cycles 1-5 were 87%, 76%, 86%, 78% and 75%, respectively. Adverse reactions were mainly headache and diarrhea, but both reactions were mild and are common in most patients treated with this type of antiemetic agent. It is concluded that tropisetron is an effective drug for the prevention of side effects of highly emetogenic drugs such as cisplatin. The dosage and schedule of tropisetron reported here can prevent both acute and delayed nausea and vomiting.

Adult↗

Ondansetron and tropisetron in the control of nausea and vomiting in children receiving combined cancer chemotherapy.

Ondansetron (Zofron, Glaxo) and tropisetron (Navoban, Sandoz) are selective serotonin (5HT3) antagonists that have proven very effective in the prevention of vomiting and nausea in adults and children receiving cancer chemotherapy. This study compared the efficacy of the two agents in the prevention of vomiting and nausea in children receiving chemotherapy for solid tumors and blood malignancies. A total of 23 children were studied in 205 chemotherapeutic cycles (116 one-day regimens and 89 multiple-day regimens). In 102 chemotherapeutic cycles the children received ondansetron as an antiemetic agent in a dose of 5 mg/m2 30 min before chemotherapy was given and then 4 mg/m2 every 8 h i.v. (group A) and in 103 cycles they received tropisetron in one dose of 0.2 mg/kg 24 h-1 i.v. (max dose 5 mg) 30 min before cytotoxic drugs administration every day they received chemotherapy (group B). The response was defined as complete in the absence of nausea and vomiting per 24 h of chemotherapy, as partial given the presence of 1-4 events of vomiting and/or nausea less than 5 h per 24 h, and as failure if there were more than 4 events of vomiting and/or nausea for more than 5 h per 24 h of chemotherapy. The response of the two groups was studied independently and depending on the degree of emetogenicity of the chemotherapeutic agents, which were divided into mildly, moderately, and highly emetogenic. The comparison of the two groups not taking into consideration the emetogenicity of the chemotherapeutic agents showed that ondansetron was more effective in 1-day regimens (P = .023), whereas the two agents were equally effective in multiple-day regimens (P = .2). The statistical analysis depending on the emetogenicity of the chemotherapeutic agents showed increased efficacy of ondansetron in mild (P = .017) and moderately emetogenic chemotherapeutic agents, whereas there was no difference in the highly emetogenic drug group. Ondansetron is found to be more effective than tropisetron in controlling acute nausea and vomiting in children receiving mild and moderately emetogenic chemotherapeutic drugs, although there is no difference in the efficacy of both antiemetic agents when highly emetogenic drugs are administered.

Adolescent↗