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PubMed1991

Controlling cancer chemotherapy-induced emesis. An update.

Cytotoxic chemotherapy can induce acute, delayed and anticipatory nausea and vomiting. The efficacy and toxicity data of the available anti-emetics and their role in chemotherapy-induced emesis are reviewed. Moreover, some pitfalls in the methodology of anti-emetic trials as well as factors known to affect the individual sensitivity of patients for the emetic challenge are illustrated. So far, high-dose metoclopramide (3-6 mg.kg-1.d-1) was the most effective single agent in the control of acute emesis. However, extrapyramidal reactions caused by its dopamine antagonism remained a major drawback. The addition of dexamethasone and/or lorazepam decreases the incidence of extrapyramidal reactions, and further improves anti-emetic control. In animals, serotonin type 3 receptor antagonists have demonstrated promising anti-emetic results against chemotherapy-induced and radiotherapy-induced emesis; the results of clinical studies are awaited. Delayed nausea and vomiting have not been studied as extensively. At present, the combination of metoclopramide and dexamethasone offers an optimal protection in approximately 50% of patients on cisplatin chemotherapy. Anticipatory nausea and emesis remain major problems, and an effective pharmacological treatment is lacking. Attempts to control this type of emesis focus on drugs with amnesic properties and on behaviour therapy.

Antiemetics↗
PubMed1993

Involvement of 5-HT3 receptors and vagal afferents in copper sulfate- and cisplatin-induced emesis in monkeys.

The emetic effects of copper sulfate and cisplatin and the potential involvement of vagal afferent fibers and 5-HT3 receptors in the emesis were investigated in cynomolgus monkeys. Retching and vomiting induced by both oral (100 mg/kg) and intravenous (20 mg/kg) copper sulfate were inhibited markedly by abdominal vagotomy. Furthermore, the emetic response induced by oral copper sulfate was strongly inhibited by intravenous ICS 205-930 (0.1 mg/kg), a 5-HT3 receptor antagonist. Cisplatin (3 mg/kg, i.v.) caused severe retching and vomiting, and the number of emetic responses was much greater than that in other species. The emetic response induced by cisplatin was inhibited markedly by abdominal vagotomy or concurrent administration of ICS 205-930 (3 x 0.1 mg/kg, i.v.). These results suggest that the monkey is more sensitive to cisplatin than other species and that the vagal afferent terminals and 5-HT3 receptors play an important role in the emetic response induced by copper sulfate and cisplatin.

Administration, Oral↗
PubMed2005

PONV: a problem of inhalational anaesthesia?

Even nowadays every third or fourth patient suffers from postoperative nausea and vomiting (PONV) after general anaesthesia with volatile anaesthetics. There is now strong evidence that volatile anaesthetics are emetogenic and that there are no meaningful differences between halothane, enflurane, isoflurane, sevoflurane, and desflurane in this respect. However, when propofol is substituted for volatile anaesthetics the risk for PONV is reduced by only about one fifth, indicating that there are other even more important causes for PONV following general anaesthesia. A main causative factor might be the use of perioperative opioids, but their impact--relative to other factors including volatile anaesthetics--has never been quantified. Patient-specific risk factors have also been shown to be clinically relevant; they are therefore included in the calculation of simplified risk scores that allow prediction of a patient's risk independent of the type of surgery. Although controversial, the well-known different incidences following certain types of surgery are most likely caused by patient-specific and anaesthesia-related risk factors. There is a common consensus that prophylaxis with anti-emetic strategies is rarely justified when the risk of PONV is low, while it is warranted in case of imminent medical risk associated with vomiting or in a patient with a high risk for PONV. A recently published large multicentre trial of factorial design, IMPACT, has demonstrated that various anti-emetic strategies are associated with a very similar and constant relative reduction rate of about 25-30% and that the main predictor for the efficacy of prophylaxis is the patient's risk for PONV. Interestingly, all anti-emetics (dexamethasone, droperidol and ondansetron) work independently, so that their combined benefit can be derived directly from the single effects. The effectiveness of the anti-emetics was also independent of a variety of risk factors, including volatile anaesthetics. This means that any anti-emetic prophylaxis for PONV induced by volatile anaesthetics is equally effective. Of course, the most logical approach for prevention would be the omission of volatile anaesthetics and nitrous oxide using a total intravenous anaesthesia with propofol. However, since volatile anaesthetics are probably not the most important risk factors, it might be even better--if appropriate--to avoid general anaesthesia by using a regional, opioid-free anaesthesia if PONV is a serious problem.

Anesthesia, Inhalation↗
PubMed2001

Action of glucocorticoids to antagonise cisplatin-induced acute and delayed emesis in the ferret.

Cisplatin 5 mg/kg, i.p. induced an acute (day 1) and delayed (days 2 and 3) emetic response in the ferret that was used to investigate the potential anti-emetic activity of several glucocorticoids. Betamethasone (0.3-3 mg/kg, i.p.) reduced the emesis occurring during the initial 0-24-h period by 71.1-99.5% (P<0.05). The action of methylprednisolone (1.0-10.0 mg/kg, i.p.) and hydrocortisone (1.0-30.0 mg/kg, i.p.) could not be assessed because the controls exhibited weak emetic responses and dexamethasone produced a non-significant 64.0% reduction at 0.3 mg/kg (P>0.05). However, all glucocorticoids dose-dependently reduced retching+vomiting during the subsequent 24-56-h period. The rank order of anti-emetic potency was betamethasone (ID(80)<0.3 mg/kg)>/=dexamethasone (ID(80)=0.32 mg/kg)>methylprednisolone (ID(80)=0.66 mg/kg)&z.Gt;hydrocortisone (ID(80)>30 mg/kg). Dexamethasone was ineffective to antagonise the retching+vomiting response during the 24-56-h period when the administration was delayed until 24 h post-cisplatin injection. None of the glucocorticoids reduced the retching+vomiting response occurring during the 56-72-h period. In conclusion, the rank order of anti-emetic potency suggests that inflammation, or mediators of inflammation, contribute to the retching+vomiting response induced by cisplatin.

Acute Disease↗
PubMed2003

Action of metyrapone and tetracosactrin to modify cisplatin-induced acute and delayed emesis in the ferret.

Cisplatin 5 mg/kg, i.p., induced an acute (day 1) and delayed (days 2 and 3) emetic response in the ferret that was used to investigate the potential anti-emetic activity of metyrapone and tetracosactrin and their potential interaction. The 11beta-hydroxylase enzymes inhibitor metyrapone 10-30 mg/kg, i.p., dose dependently potentiated the acute cisplatin-induce retching+vomiting response by up to 219% at the highest dose (P<0.001) but failed to affect significantly delayed emesis (P>0.05). The adrenocorticotropic hormone (ACTH) mimetic tetracosactrin 0.1 mg/kg, i.m., antagonised significantly the acute and delayed emetic response by 98% (P<0.01) and 75% (P<0.001), respectively. The anti-emetic action of tetracosactrin on acute but not delayed emesis was prevented by combination with metyrapone 10 mg/kg, i.p. Tetracosactrin 0.1 mg/kg, i.m., failed to modify apomorphine (0.25 mg/kg, s.c.)-induced emesis. The potential anti-emetic mechanism of action of metyrapone and tetracosactrin to modulate emesis is discussed.

Acute Disease↗
PubMed1999

Modulation of emesis by fentanyl and opioid receptor antagonists in Suncus murinus (house musk shrew).

The anti-emetic mechanism of action of fentanyl to inhibit nicotine (5 mg/kg, s.c.)-induced emesis was investigated in Suncus murinus. The anti-emetic action of fentanyl (40 microg/kg, s.c.) was antagonised by the opioid receptor antagonists naltrexone (1 mg/kg, s.c.), naloxone (1 mg/kg, s.c.), M8008 (16S-methylcyprenorphine; 1 mg/kg, s.c.) and MR 2266 (5,9-diethyl-2-(3-furylmethyl)2'-hydroxy-7,7-benzomorphan; 1 mg/kg) but not by naloxone methylbromide (1 mg/kg, s.c.), naloxone methyliodide (1 mg/kg, s.c.), naltrindole (1 mg/kg, s.c.), DIPPA (2-(3,4-dichlorophenyl)-N-methyl-N-[1S)-1-(3-isothiocyanatophenyl)-2-(1- pyrrolidinyl)-ethyl]acetamide; 3 mg/kg, i.p.) or naloxonazine (35 mg/kg, i.p.). This indicates an involvement of mu2-opioid receptors within the brain to mediate the anti-emetic effect of fentanyl. In other studies, naloxone 10-60 mg/kg, s.c. induced dose-related emesis but naltrexone was only emetic at 60 mg/kg, s.c. and naloxone methylbromide failed to induce emesis at doses up to 60 mg/kg, s.c. The emesis induced by a high dose of naloxone 60 mg/kg, s.c. was antagonized by CP-99,994 ((+)-(2S,3S)-3-(2-methoxybenzylamino)-2-phenylpiperidine; 3-30 mg/kg, i.p.), 8-OH-DPAT, ((+/-)-8-hydroxy-dipropylaminotetralin; 0.003-0.3 mg/kg, s.c.), buspirone (3 mg/kg, s.c.) and fluphenazine (1-3 mg/kg, i.p.) but not by naltrexone (1-30 mg/kg, s.c.), metoclopramide (0.3-3 mg/kg, i.p.), sulpiride (0.3-3 mg/kg, i.p.), domperidone (0.1-3 mg/kg, i.p.), ondansetron (0.3-3 mg/kg, i.p.), granisetron (0.3-3 mg/kg, i.p.), scopolamine (0.3-3 mg/kg, i.p.) or promethazine (0.3-3 mg/kg, i.p.). The data is discussed in relation to opioid receptor mechanisms moderating emesis and the identification of potential sites of drug action available to inhibit the emetic reflex.

Animals↗
PubMed2000

Characterization of lipopolysaccharide-induced emesis in conscious piglets: effects of cervical vagotomy, cyclooxygenase inhibitors and a 5-HT(3) receptor antagonist.

The emetic response to intraperitoneal (i.p., 0.5, 2, 8 mg kg(-1)) and intravenous (i.v., 200 microg kg(-1)) administration of bacterial lipopolysaccharides (LPS) was characterized in conscious piglets observed for 4 h. The latencies and the incidence of the emetic response to LPS (i.p.) decreased and increased, respectively, in a dose-dependent manner. In 14 additional piglets, a bilateral vagotomy performed 4 h prior to LPS administration abolished the vomiting induced by i.p. LPS (2 mg kg(-1)), and decreased its incidence by 77% in the i.v. injected animals. Sham-operated animals (n=6) exhibited a similar emetic pattern to the controls injected intraperitoneally with LPS (2 mg kg(-1)). In 7 piglets, the administration of granisetron, a 5-HT(3) receptor antagonist (i.v., 2 mg kg(-1)), 30 min prior to the i.p. LPS injection (2 mg kg(-1)) failed to reduce significantly the emetic activity; whereas, in 6 animals, a combination of meloxicam (0.3 mg kg(-1)) and indomethacin (5 mg kg(-1)), two cyclooxygenase (COX) inhibitors, administered per os 1.5 h prior to the i.p. LPS (2 mg kg(-1)) abolished the emetic response to endotoxins. The present results show that the activation of the medullary "vomiting centre" in response to i.p. administration of LPS is mediated via vagal afferents and is likely to involve prostaglandins.

Animals↗
PubMed2003

Randomized, double-blind, placebo-controlled, dosed-finding study of the antiemetic effects and tolerability of ramosetron in adults undergoing middle ear surgery.

BACKGROUND: Ramosetron is a selective serotonin receptor antagonist (SSRA) that is approved for the treatment of emetic symptoms induced by cytotoxic drugs in Japan. We have reported that ramosetron 0.3 mg had comparable efficacy to granisetron 3 mg, another SSRA, in preventing emetic symptoms in adults in the first 48 hours after the start of anesthesia for middle ear surgery. Although it has been shown that a high dose of ramosetron can cause adverse effects (AEs), such as severe headache, the minimal effective dose of ramosetron is unknown. OBJECTIVE: The aim of this study was to determine the minimum effective and tolerable dose of ramosetron needed to prevent postoperative emetic symptoms in adult patients undergoing middle ear surgery. METHODS: This randomized, double-blind, placebo-controlled, dose-finding study was conducted at the Department of Anesthesiology, Toride Kyodo General Hospital (Toride, Japan). Patients aged > or =20 years scheduled for middle ear surgery were randomized to receive either placebo or ramosetron at 1 of 3 doses (0.15, 0.3, or 0.6 mg), regardless of body weight, i.v. immediately before anesthesia induction. Emetic symptoms (nausea, retching, or vomiting) occurring from 0 to <24 and 24 to 48 hours after the start of anesthesia were recorded. Other AEs also were assessed. RESULTS: A total of 100 patients (55 women, 45 men; mean [SD] age, 44 [12] years; mean [SD] body weight, 56 [8] kg; mean [SD] height, 159 [8] cm) were enrolled. Each treatment group comprised 25 patients. The treatment groups were comparable with regard to demographic characteristics and type of surgery After the second 24 hour postanesthesia period, significantly more patients in the ramosetron 0.3-mg and 0.6-mg groups were emesis free than in the placebo group (both P<0.001). The number of emesis-free patients in the ramosetron 0.15-mg group and the placebo group were similar after both study periods. No significant difference in antiemetic efficacy was found between the ramosetron 0.3-mg and 0.6-mg groups. No relationship between body weight and the efficacy of ramosetron was observed. The incidence of AEs was similar in all 4 groups. CONCLUSIONS: Ramosetron 0.3 mg, regardless of body weight, was more effective than either ramosetron 0.15 mg or placebo and as effective as ramosetron 0.6 mg for the prevention of emetic symptoms in the first 48 hours after the start of anesthesia in this selected population of adult patients who underwent middle ear surgery.

Adult↗
PubMed2004

Randomized, double-blind comparison of subhypnotic-dose propofol alone and combined with dexamethasone for emesis in parturients undergoing cesarean delivery.

BACKGROUND: Nausea, retching, and vomiting are common in parturients undergoing cesarean delivery performed under regional anesthesia. Subhypnotic-dose propofol 1.0 mg/kg per hour has been used to reduce the incidence of these emetic symptoms. Dexamethasone has been shown to reduce chemotherapy-induced emesis when added to an antiemetic regimen. OBJECTIVE: The aim of this study was to examine the difference in efficacy and tolerability between subhypnoticdose propofol 1.0 mg/kg per hour alone and combined with dexamethasone 8 mg for reducing postdelivery emetic episodes in parturients undergoing cesarean delivery. METHODS: In a randomized, double-blind trial, parturients received IV placebo (saline) or dexamethasone 8 mg followed by a continuous infusion of propofol at subhypnotic dose (1.0 mg/kg per hour) immediately after clamping of the umbilical cord. Intraoperative, postdelivery emetic episodes and safety assessments were performed by an investigator. RESULTS: One hundred twenty parturients (mean [SD] age, 29 [5] years; age range, 21-38 years; mean [SD] height, 158 [7] cm; height range, 145-172 cm; mean [SD] body weight, 72 [8] kg; weight range, 54-90 kg) were enrolled in the study, 60 in each treatment group. The treatment groups were comparable with respect to maternal demographics and operative management. The rate of emetic symptoms (nausea, retching, and vomiting) in an intraoperative, postdelivery period was lower in patients who received the combination regimen than in those who received subhypnotic-dose propofol 1.0 mg/kg per hour alone (5% [3/60] vs 20% [12/60], respectively; P = 0.012). No clinically important adverse events attributable to the study drug were observed in either group. CONCLUSION: In the parturients undergoing cesarean delivery performed under spinal anesthesia in this study, the combination of subhypnotic-dose propofol 1.0 mg/kg per hour and dexamethasone 8 mg was more effective than propofol alone for reducing the incidence of postdelivery emetic symptoms.

Adult↗
PubMed1987

A clinical trial using syrup of ipecac and activated charcoal concurrently.

A prospective study was conducted to determine if the emetic effects of syrup of ipecac are preserved when activated charcoal is administered prior to emesis. Ten overdose patients who fulfilled the entrance criteria for the study were administered 60 mL syrup of ipecac by a nasogastric tube followed immediately by 500 mL of tap water. Ten minutes after the ipecac was administered, an aqueous slurry of 50 g activated charcoal diluted to 500 mL was instilled down the nasogastric tube and the tube was removed. Emetic response and time to emesis were recorded. Thirty minutes after emesis subsided, a second dose of 50 g activated charcoal (with sorbitol) was administered orally. Emetic responses were noted in all ten patients. The patients averaged 3.7 emetic episodes. Emesis commenced in an average of 13.8 minutes from the start of ipecac administration and concluded in an average of 45.9 minutes. These results in patients are similar to those observed in a previously reported volunteer group similarly treated. This protocol allows early administration of activated charcoal while preserving the emetic properties of syrup of ipecac in the patients treated.

Adolescent↗
PubMed1998

Droperidol-ondansetron combination versus droperidol alone for postoperative control of emesis after total abdominal hysterectomy.

STUDY OBJECTIVES: To investigate the hypothesis that the combination of ondansetron and droperidol would be more effective than droperidol alone in reducing nausea and vomiting. DESIGN: Randomized, doubleblind study. SETTING: Magee-Womens Hospital, Pittsburgh, Pennsylvania. PATIENTS: 160 healthy, ASA physical status I and II, female patients scheduled for total abdominal hysterectomy. INTERVENTIONS: After induction of anesthesia with propofol, Group 1 received intravenous (i.v.) droperidol 1.25 mg plus i.v. ondansetron 4 mg. Group 2 received i.v. droperidol plus i.v. saline. MEASUREMENTS AND MAIN RESULTS: The complete response (no emesis, no rescue) for Group 1 was 36 of 80 patients (45%) versus 30 of 80 patients (38%) in Group 2 (p = 0.21). In Group 1, 42 of 80 patients (53%) required rescue antiemetic as compared with 44 of 80 patients (55%) in Group 2 (p = 0.43). There were 72 total rescues in Group 1 versus 73 in Group 2, (p = 0.24). Mean time until first rescue was 578 +/- 429 minutes in Group 1 and 418 +/- 354 minutes in Group 2, (p = 0.03). In Group 1, 81 % (34/42) were rescued for nausea only versus 90% (39/44) of Group 2 (p = 0.16). In Group 1, 21% of patients (17/80) had at least one emetic episode versus 34% (27/80) of Group 2 patients (p = 0.05). There were 31 emetic episodes in Group 1 versus 72 episodes in Group 2. (p = 0.02). Mean time to the first emetic episode was 699 +/- 403 minutes in Group 1 and 616 +/- 376 minutes in Group 2, (p = 0.23). CONCLUSION: For patients undergoing total abdominal hysterectomies, the addition of ondansetron to droperidol increases the time until first rescue and reduces the number of emetic episodes, as well as the percentage of patients, having at least one emetic episode.

Adult↗
PubMed1998

Efficacy of 5-HT3 receptor antagonists in radiotherapy-induced nausea and vomiting: a quantitative systematic review.

5-HT3 receptor antagonists are used to treat radiation-induced sickness. The purpose of this study was to define anti-emetic efficacy and potential for harm of these drugs in radiotherapy. A systematic search, critical appraisal and quantitative analysis of relevant data using the number-needed-to-treat or harm (NNT/H) were conducted. Acute (0 to 24h) and delayed (beyond 24 h) anti-emetic efficacy were analysed separately. Data from 1,404 patients were found in 40 trials published in 36 reports. Data from 197 patients receiving ondansetron or granisetron in five randomised trials were regarded as valid according to preset criteria. One placebo-controlled trial had 10 patients per group and in this ondansetron was not significantly different from placebo. In a larger (n = 105) placebo-controlled trial, ondansetron was significantly more efficacious than metoclopramide for complete control of acute vomiting (NNT 2.2, 95% confidence interval (CI) 1.7-3.3) and acute nausea (NNT 3.6, 95% CI 2.2-10.2). Three trials reported delayed outcomes with ondansetron or granisetron: there was no evidence of any difference compared with placebo or other anti-emetics. Two trials reported no acute or delayed but a 'worst day' outcome; in these ondansetron's antivomiting effect was significantly better than placebo (NNT 4.4, 95% CI 2.5-23) or prochlorperazine (NNT 3.8, 95% CI 2.4-10.3), but not its antinausea effect. Constipation and headache were associated significantly with 5-HT3 receptor antagonists compared with other anti-emetics or placebo (NNH 6.4 and 17.1, respectively). Only 14% of published data enabled valid estimation of the anti-emetic efficacy of 5-HT3 receptor antagonists in radiotherapy. There was some evidence that these drugs prevent acute vomiting: 40% of treated patients will benefit (NNT approximately 2.5). The evidence for nausea was less clear. There was no evidence that these drugs are of any benefit beyond 24 h. There was evidence that they produce specific adverse effects.

Antiemetics↗
PubMed1998

Navoban (tropisetron, ICS 205-930) and dexamethasone combination in the prevention of vomiting for patients receiving preconditioning high-dose chemotherapy before marrow transplantation.

The anti-emetic efficacy of a combination of tropisetron and dexamethasone was studied in 33 patients who underwent bone marrow transplantation. Another 50 patients receiving conventional anti-emetic therapies in bone marrow transplantation served as control. On the first and second days of preconditioning chemotherapy, 51% and 36% respectively of patients in the tropisetron and dexamethasone group did not experience vomiting, compared with only 12% and 10% of control group patients (P < 0.001). The mean number of episodes of vomiting in the tropisetron and dexamethasone group was also significantly lower than in the control group (0.97+/-1.65 vs 3.50+/-2.45 and 1.30+/-1.40 vs 4.44+/-2.91 respectively, both P < 0.001). Control of vomiting in the two groups was not significantly different during days 3-6. Analysis of patients receiving busulfan and cyclophosphamide as the preconditioning regimen still showed better anti-emetic control in the tropisetron and dexamethasone group than in the control group on the first two days of treatment (total control rate 33.3% vs 6.5% and 44.4% vs 12.9% respectively, P < 0.001). Patients given tropisetron and dexamethasone combination more frequently suffered from dizziness and burning sensation of the chest. However, diarrhea and extrapyramidal symptoms were the most frequent adverse effects seen after using conventional anti-emetic combination. The combination of tropisetron and dexamethasone was thus superior to conventional anti-emetic combinations in preventing vomiting during preconditioning period of bone marrow transplantation. The adverse effects of this combination were minimal and well tolerated by patients.

Adolescent↗
PubMed1996

Droperidol/ondansetron combination controls nausea and vomiting after tubal banding.

The antiemetic activity of droperidol is attributed to antagonizing the dopaminergic neurons of the chemoreceptor trigger zone. Ondansetron is a serotonin (5HT) receptor antagonist at both peripheral and central 5-HT3 receptor sites with no known action on dopamine-mediated activity. We hypothesized that the combination of these two antiemetics would be more effective than droperidol alone. Women with ASA classified physical status I or II, scheduled for laparoscopic tubal banding, participated in a randomized double-blind clinical trial using a standardized anesthesia regimen. Within 15 min after induction of anesthesia, Group 1 (n = 60) received IV droperidol 1.25 mg and ondansetron 4 mg and Group 2 (n = 60) received IV droperidol 1.25 mg and saline. Before surgery and during recovery at 1, 2, and 24 h, emetic episodes, nausea, pain, drowsiness, medications taken, and adverse events were recorded. The complete response (no emesis, no rescue) for Group 1 was 55 of 60 (91.6%) versus 47 of 60 (78.3%) in Group 2 (P = 0.04). No patient needed rescue antiemetic medication in Group 1, whereas 5 of 60 (8.3%) patients were rescued in Group 2 (P = 0.03). There were seven emetic episodes in five patients in Group 1 and 30 emetic episodes in 12 patients in Group 2 over the 24-h study period (P = 0.03). The time to the first emetic episode was more than twice as long for Group 1 than Group 2 (P = 0.03) and total nausea scores were lower in Group 1 than Group 2 (P = 0.01). The droperidol/ondansetron combination was significantly superior to droperidol in complete response, time to and number of emetic episodes, and the incidence and severity of nausea in women having tubal banding.

Antiemetics↗
PubMed1991

Double-blind randomized cross-over trial comparing methylprednisolone with placebo in chemotherapy-induced nausea and vomiting: a study with special reference to efficacy parameters.

Sixty-one patients with breast cancer who received chemotherapy participated in a double-blind randomized cross-over study with methylprednisolone (MP) 250 mg as a single i.v. injection before chemotherapy and placebo as antiemetic treatment. The determining efficacy parameter was preference. Other parameters used were a visual analogue scale for nausea, a categorical four-point nausea intensity scale recorded by a nurse observer, emetic amounts, emetic episodes, acceptance of nausea and vomiting, and global assessments for nausea and vomiting. MP showed a significant antiemetic effect compared with placebo which was most pronounced for moderately emetogenic chemotherapy. The visual analogue scale, emetic amounts, acceptance and global assessments were easy to handle and showed coherence with preference, whereas nausea intensity and emetic episodes were resource demanding to record and showed no coherence with preference. It is concluded that for a precise evaluation of nausea and vomiting the visual analogue scale and emetic amounts are most reliable; for ambulatory patients global assessments seem to be sufficient.

Adult↗
PubMed2000

Efficacy and safety of oral granisetron versus i.v. granisetron in patients undergoing peripheral blood progenitor cell and bone marrow transplantation.

This randomized, controlled, double-blind pilot study assessed the efficacy and safety of oral versus i.v. granisetron, both in combination with non-5-HT3 antiemetics, in preventing emesis caused by high-dose chemotherapy. Fifty-one patients who underwent peripheral blood progenitor cell transplantation (PBPCT) or bone marrow transplantation (BMT) were evaluated. Efficacy was assessed by the number of emetic episodes during the worst 24 h period. A complete response (CR) was defined as no vomiting, partial response (PR) as less than three emetic episodes and failure as three or more emetic episodes. Patients who received oral granisetron experienced significantly (p<0.0008) fewer emetic episodes than those who received i.v. granisetron; however, the number of emetic episodes over the worst 24 h was similar between the oral and i.v. granisetron groups (13 and 15, respectively), as were the overall response rates (CR+PR, 54.5 and 41.4%, respectively). Both dosage forms were well tolerated. Based on these findings, further comparative studies of oral granisetron are warranted in patients undergoing PBPCT or BMT.

Administration, Oral↗
PubMed1995

Randomized double-blind crossover ondansetron-dexamethasone versus ondansetron-placebo study for the treatment of chemotherapy-induced nausea and vomiting in pediatric patients with malignancies.

PURPOSE: To determine whether the addition of dexamethasone to ondansetron (OND + DEX) is a more effective antiemetic regimen than ondansetron (OND) alone in children receiving chemotherapy. PATIENTS AND METHODS: Children who had solid tumors and who were receiving highly emetogenic chemotherapy, including cisplatin, carboplatin, cyclophosphamide, and ifosfamide, were randomized (1:1) in a double-blind fashion to receive either OND 0.15 mg/kg intravenously (i.v.) 30 min before and 4 and 8 h after chemotherapy and placebo, or OND + DEX (same OND doses plus DEX 8 mg/m2 i.v. 30 min before chemotherapy, followed by 16 mg/m2 in divided doses) as antiemetics. The patients were crossed over to the other antiemetic regimen when receiving an identical course of chemotherapy. Patients were monitored for emetic episodes, nausea, appetite, sense of well-being, and antiemetic adverse events. RESULTS: A total of 33 patients were evaluated. Sixty-one percent of the patients receiving OND + DEX regimens had a complete response for emetic episodes as compared with 23% with OND alone. Combined complete and major responses (two or less emetic episodes) were 86% for OND + DEX and 67% for OND. Failure for emetic episodes (more than five vomitings/day) were seen only in 7-10% of the total population. Minimal or no nausea was experienced in 74% of OND + DEX courses and in 52% of the OND courses. Appetite was better in OND + DEX courses (p = 0.006). Both antiemetic arms had similar adverse events. Mild to moderate sedation occurred in about half of the courses, followed by restlessness (29%), headache (17%), diarrhea (17%), and hiccups (2%). CONCLUSION: The combination of ondansetron and dexamethasone is superior to ondansetron alone to control emetic episodes in children receiving highly emetogenic chemotherapy (p = 0.04).

Adolescent↗
PubMed1994

Analgesics and ENT surgery. A clinical comparison of the intraoperative, recovery and postoperative effects of buprenorphine, diclofenac, fentanyl, morphine, nalbuphine, pethidine and placebo given intravenously with induction of anaesthesia.

1. Vomiting and restlessness following ENT and eye surgery are undesirable, and may be related to the emetic and analgesic effects of any analgesic given to augment anaesthesia during surgery. 2. To rationalise the choice of analgesic for routine ENT surgery we examined the intraoperative, recovery and postoperative effects following the administration of either buprenorphine (3.0 to 4.5 micrograms kg-1), diclofenac (1 mg kg-1), fentanyl (1.5 to 2.0 micrograms kg-1), morphine (0.1 to 0.15 mg kg-1), nalbuphine (0.1 to 0.15 mg kg-1), pethidine (1.0 to 1.5 mg kg-1) or saline (as control) given with the induction of anaesthesia in 374 patients. A standardised anaesthetic technique with controlled ventilation using 0.6-0.8% isoflurane in nitrous oxide and oxygen was employed. The study population constituted 7 similar groups of patients. 3. Intraoperatively, their effects on heart rate and blood pressure, airway pressure and intraocular pressure, were similar. This implies, most surprisingly, that neither their analgesic nor their histamine releasing effects were clinically evident during surgery. By prolonging the time to extubation at the end of anaesthesia, only buprenorphine, fentanyl, morphine and pethidine provided evidence of intraoperative respiratory depression. 4. Postoperatively, buprenorphine was associated with severe respiratory depression, prolonged somnolence, profound analgesia and the highest emesis rate. Diclofenac exhibited no sedative, analgesic, analgesic sparing, emetic or antipyretic effects. Fentanyl provided no sedative or analgesic effects, but was mildly emetic. Morphine provided poor sedation and analgesia, delayed the requirement for re-medication and was highly emetic. Nalbuphine and pethidine produced sedation with analgesia during recovery, a prolonged time to re-medication and a mild emetic effect. None provided evidence, from analysis of postoperative re-medication times and analgesic consumption, of any pre-emptive analgesic effect. 5. We conclude that nalbuphine (mean dose 0.13 mg kg-1) and pethidine (mean dose 1.35 mg kg-1), given individually as a single i.v. bolus during induction of anaesthesia, are the most efficacious analgesics for routine in-patient ENT surgery.

Adolescent↗