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PubMed1992

Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.

The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. Episodes of emesis, nausea scores, adverse events, vital signs, and laboratory values were assessed before and during the 24 h after study drug administration. Patients were evaluated for the first 2 h in the Post-Anaesthesia Care Unit then followed up for the next 22 h. Complete response was defined as no emetic episodes, no nausea or no rescue anti-emetic medication. For the 0-24 h study period, complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% in the 1, 4, and 8 mg ondansetron groups, respectively. Mean nausea scores (scale of 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron [2.2 (1 mg), 1.7 (4 mg), and 2.1 (8 mg)] compared to placebo (3.0). The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.

Adolescent↗
PubMed1992

Neuropharmacology of emesis in relation to clinical response.

5-HT3 receptor antagonists such as ondansetron, granisetron, ICS205-930 and zacopride are highly effective in the ferret, cat or dog to prevent emesis caused by cisplatin and other chemotherapeutic agents, and radiation treatment. The anti-emetic effects may be mediated centrally in the area postrema and associated structures of the emetic reflex such as the nucleus tractus solitarius, which have a very high density of 5-HT3 receptors. Additional sites of action may be found on the 5-HT3 receptors located on the vagus nerve or enteric neuronal elements in the gastro-intestinal tract. The precise site(s) and mechanism(s) of action of different cytotoxic treatments to induce emesis remains to be determined, but appears to involve a common action on a 5-HT3 system. The 5-HT3 receptor antagonists do not impair normal behaviour and, in particular, fail to affect the extrapyramidal motor system and do not cause sedation. Of potential benefit, the 5-HT3 receptor antagonists have an anxiolytic profile of action in rodent and primate models. The 5-HT3 receptor antagonists are revealed as an important group of drugs to prevent emesis induced by a wide range of cytotoxic treatments.

Animals↗
PubMed2003

Children with Rolandic spikes and ictal vomiting: Rolandic epilepsy or Panayiotopoulos syndrome?

Centrotemporal spikes are the EEG marker of Rolandic epilepsy, while ictus emeticus is one of the main seizure manifestations of Panayiotopoulos syndrome. Ictus emeticus has not been reported in Rolandic epilepsy. Out of a population of 1340 children with focal afebrile seizures we studied 24 children who had emetic manifestations in at least one seizure and centrotemporal spikes in at least one EEG. They were of normal neurological status and had a follow-up of at least two years after the last seizure. All children had sleep EEG following sleep deprivation. Two groups of patients were identified. Group A (12 patients) with EEG centrotemporal spikes only and group B (12 patients) with centrotemporal spikes and spikes in other locations. In 21 patients, ictal emetic manifestations culminated in vomiting and in three only nausea or retching occurred. The commonest presentation was ictus emeticus at onset followed by deviation of the eyes or staring, loss of contact and floppiness. In 79%, seizures occurred during sleep. Autonomic status epilepticus occurred in 37.5%. The mean age at onset was 5.3 years. Overall analysis of the clinical and EEG data points out that the vast majority of these patients primarily suffer from Panayiotopoulos syndrome. Twenty patients (83%) had ictal semiology typical of Panayiotopoulos syndrome, but five also had concurrent Rolandic symptoms and four later developed pure Rolandic seizures. The other four patients (17%) had typical Rolandic seizures with concurrent ictus emeticus. These findings suggest a link between Rolandic epilepsy and Panayiotopoulos syndrome, the two most important phenotypes of the benign childhood seizure susceptibility syndrome.

Adolescent↗
PubMed1992

Single-dose ondansetron for the prevention of cisplatin-induced emesis: efficacy results.

Ondansetron 0.15 mg/kg, given intravenously (IV) every 4 hours for three doses, has replaced metoclopramide as standard antiemetic therapy for patients receiving cisplatin-based chemotherapy. Several clinical observations suggested that ondansetron may be effective when given in a single dose: (1) demonstration of efficacy over a wide dose range, (2) similar efficacy with dosing intervals of 2, 4, 6, and 8 hours, and (3) efficacy of single-dose regimens with high-dose metoclopramide and other 5-hydroxytryptamine3 antagonists. In this study, patients receiving cisplatin-based chemotherapy were randomized to receive one of three ondansetron dosing regimens: ondansetron 0.15 mg/kg IV every 4 hours x 3 (standard schedule), ondansetron 32 mg IV x 1, or ondansetron 8 mg IV x 1. All patients were chemotherapy naive, at least 18 years of age, Karnofsky performance status > or = 60%, and inpatients. The number of emetic episodes, nausea, and food intake were measured during the 24 hours following cisplatin administration. Six hundred eighteen evaluable patients were randomized to the three ondansetron treatment groups; 301 received moderate-dose cisplatin (50 to 70 mg/m2) and 317 received high-dose cisplatin (> or = 100 mg/m2). Patients in both cisplatin groups receiving ondansetron 32 mg had a higher complete response rate, lower failure rate, fewer total emetic episodes, less nausea, and more food intake than did patients receiving ondansetron 8 mg. In addition, the 32-mg schedule was superior to the standard three-dose schedule in that it had a lower failure rate and higher food intake and was equivalent to the standard regimen in all other comparisons. All three schedules were well tolerated. Ondansetron 32 mg given prior to cisplatin is superior to a single 8-mg dose and is at least as effective, if not superior to, the standard three-dose schedule (0.15 mg/kg every 4 hours). On the basis of these data, ondansetron 32 mg should be considered standard therapy in patients receiving cisplatin-based chemotherapy and should be the schedule with which new antiemetics and alternate dosing schedules are compared.

Cisplatin↗
PubMed1992

Efficacy of ondansetron tablets in the management of chemotherapy-induced emesis: review of clinical trials.

The selective 5-hydroxytryptamine3 antagonist ondansetron has been shown to be effective in preventing nausea and vomiting associated with highly emetogenic cisplatin chemotherapy. Two multicenter, placebo-controlled, dose-comparison studies (S3A-361 and S3A-362) were undertaken to investigate the efficacy and safety of oral ondansetron in patients receiving non-cisplatin, cyclophosphamide-based regimens in the outpatient setting. Chemotherapy-naive patients undergoing their first cycle of cyclophosphamide-based (> or = 500 mg/m2) chemotherapy were randomized to receive placebo or ondansetron, 1, 4, or 8 mg, three times per day for 3 days. In addition to cyclophosphamide, all patients received doxorubicin, methotrexate, or another low-to-moderately emetogenic agent. In study S3A-361, 318 of 349 patients were evaluable for efficacy; 297 of 324 patients in study S3A-362 were evaluable for efficacy. All patients in both studies were evaluable for safety. All ondansetron groups were superior to placebo groups in both studies for all measured efficacy parameters. In the two studies combined, 14%, 47%, 65%, and 66% of patients in the placebo, 1-, 4-, and 8-mg ondansetron groups, respectively, experienced no emetic episodes. The rate of therapeutic failure was statistically lower in the ondansetron groups in both studies compared with the placebo groups. In addition, therapeutic failure decreased in a dose-dependent manner. Severity of nausea, food intake, time to first emetic episode, and need for rescue antiemetics were also improved for the ondansetron groups. When the patients were stratified for doxorubicin-containing regimens, those patients receiving doxorubicin had a lower response rate with placebo and ondansetron than those on non-doxorubicin regimens. However, a dose-related improvement in efficacy was still observed with ondansetron in this subset of patients. In patients receiving the more emetogenic high-dose cyclophosphamide (> or = 600 mg/m2) regimens, a dose-related improvement in efficacy also was observed. In conclusion, oral ondansetron was found to be an effective and safe antiemetic for patients receiving cyclophosphamide-based chemotherapy in the outpatient setting. The 8-mg dose was optimal, particularly in patients receiving doxorubicin-containing or high-dose cyclophosphamide regimens.

Adult↗
PubMed1992

Radiation-induced emesis: effects of ondansetron.

The incidence, severity, and onset of radiation-induced emesis (RIE) are related to field size, site, and dose per fraction. Radiation-induced emesis can occur (1) within 2 to 3 weeks in approximately 50% of patients after conventional fractionated radiotherapy (200 cGy/fraction) to the upper abdomen, (2) acutely in more than 90% of patients receiving fractionated total body irradiation (TBI) for bone marrow transplantation, and (3) within 30 to 60 minutes in more than 80% of patients following single high-dose (> 500 cGy)/large field hemibody irradiation (HBI). The increased frequency of emesis associated with TBI and HBI has renewed the interest in the mechanism and treatment of RIE. A number of studies have reported a significant difference in the incidence of emesis following doses of > or = 500 cGy to the upper-mid (> 80%) and lower (20% to 40%) hemibody. The data suggested that the organ responsible for emetic response was in the upper abdomen. However, the mechanism of RIE is not well understood, although degradation products from normal tissues and tumor have been suggested. The introduction and effectiveness of the 5-hydroxytryptamine3 receptor antagonists in chemotherapy-induced emesis and the location of these receptors in the upper abdomen (possible site of the radiation-associated emetic response) suggested that this group of compounds may have a role in RIE. Lucraft and Palmer (Clin Radiol 33:621-622, 1982) reported no differences between levonantradol and chlorpromazine in preventing RIE in patients treated with single doses of more than 10 Gy to a small upper abdominal field. Priestman (Eur J Cancer Clin Oncol 25:529-533, 1989 [Suppl]) reported on a pilot and randomized study with ondansetron after single doses of 8 to 10 Gy to the upper abdomen. In the pilot study, ondansetron achieved major or complete control of vomiting in 77% to 90% of patients; subsequently, he reported a significant difference between ondansetron (97%) and metoclopramide (45%) in controlling RIE on the day of radiotherapy. Hewitt et al (Bone Marrow Transpl 7:431-433, 1991) reported a complete or major response on 93% of the days of ondansetron therapy during pretreatment therapy with cyclophosphamide and TBI for bone marrow transplantation. A preliminary analysis of 41 patients treated with HBI at the Rex Cancer Center confirms the role of ondansetron in RIE. Twenty-eight patients (upper-mid 16 patients/lower HBI 12 patients) did not receive pretreatment antiemetics (group A); seven received non-ondansetron pre-HBI (group B); and six received ondansetron (group C).(ABSTRACT TRUNCATED AT 400 WORDS)

Antiemetics↗
PubMedDate not supplied

Subcutaneous levomepromazine rescue (SLR) for high grade delayed chemotherapy-induced emesis (DCIE).

BACKGROUND: Delayed chemotherapy-induced emesis (DCIE) has significant patient and health economic impact. Up to 50% of patients on chemotherapy may develop DCIE. There is no accepted standard of care for DCIE. PATIENTS AND METHODS: A prospective observational study of patients with high grade DCIE needing admission to hospital over a 2-year period. Single cycle delayed anti-emetic failure (DAF) per patient is reported. Twenty-five mg/24 hours subcutaneous levomepromazine rescue (SLR) was used. Control of nausea and vomiting was recorded in 2 time-periods: 0 to 24 hours and 24 to 48 hours. RESULTS: Thirty-two patients (12 male, 20 female) required SLR. Median age 58 years (r. 35-76). Grade 0 nausea and vomiting (N and V) was attained within 24 hours in 75% and 81% of patients, respectively, and in 94% of patients for both by 48 hours. Side-effects of sedation and hypotension were mild. CONCLUSION: Levomepromazine has efficacious anti-emetic qualities in the rescue of patients with high grade DCIE needing hospital admission.

Adult↗
PubMed2004

[Tropisetron in attenuation of nausea and vomiting in patients undergoing high-dose chemo-radiotherapy supported by autologous peripheral blood stem cell transplantation].

BACKGROUND & OBJECTIVE: High-dose conditioning regimens of chemo-radiotherapy with or without total body irradiation (TBI) frequently induces nausea and vomiting in patients who are supported with stem cell transplantation. 5-Hydroxytrypamine(3) (5-HT(3)) receptor antagonists, when used alone, are unsatisfactory in the attenuation of emesis; Furthermore, consensus about their optimal dose, optimal dosing frequency and the combined use with other anti-emetic drugs are still controversial. The main objective of this trial was to observe the anti-emetic effectiveness and side effects of tropisetron plus dexamethasone and diphenhydramine (Group A) and tropisetron alone (Group B) on the patients undergoing high-dose treatment for peripheral blood stem cell (PBSC) mobilization and transplantation. METHODS: From December 1998 to September 2002, 68 patients undergoing autologous peripheral blood stem cell transplantation were allotted into this study. All the eligible patients were divided into group A or B non-randomly to compare the efficacy of the two regimens in the prevention of nausea and vomiting induced by high-dose treatment. Regimens:40 patients in group A were given tropisetron 5 mg,iv,every 12 h plus dexamethasone 5-10 mg, iv, daily, and diphenhydramine, 20 mg, im, daily. Twenty-eight patients in group B were received tropisetron alone,5 mg,iv,every 12h. RESULTS: For nausea during the acute phase, complete response rates of group A and B were 55% and 46.4%, with an overall response rates of 97.5% and 85.7%,of which the difference was insignificant (P >0.05). For vomiting during the acute phase, complete response rates of group A and B were 77.5% and 78.6%, with an overall response rates of 90% and 92.9%, of which the difference was insignificant (P >0.05). For delayed phase, both the complete response and overall response rates were higher in group A, with the difference significant (P< 0.05). The side effects of both regimens were mild. Common side effects including abdomen discomfort,headache,heavy head and constipation did not necessitate the discontinuity of high-dose treatment. CONCLUSION: The combination of tropisetron with dexamethasone and diphenhydramine is more effective than tropisetron alone in the control of nausea and vomiting induced by high-dose chemotherapy with or without TBI, which is especially more effective in the delayed phase of nausea and vomiting. The side effects of the combination regimen were mild. Based on these findings, we stress the importance of large randomized trials in the future.

Adolescent↗
PubMed1992

The incidence of postoperative nausea and vomiting: a retrospective comparison of alfentanil versus sufentanil.

Postoperative nausea and vomiting have been associated with the use of intravenous narcotics, and nitrous oxide may worsen the emetic effects of narcotics. Alfentanil and sufentanil are two synthetic derivatives of fentanyl; alfentanil has a shorter wake-up time than fentanyl, and sufentanil is equivalent to fentanyl. In order to study comparative emetic properties of these two drugs, patients in two different cities were randomly allocated to two different groups and retrospectively compared. Group I received sufentanil N2O/O2 with 0.25% isoflurane. Group II received alfentanil N2O/O2 with 0.25% isoflurane. With group I, the overall incidence of nausea was 31% and of vomiting was 6.2%. For group II, the overall rate for nausea was 38.2% and 8.8% for vomiting. Statistically, there was no significant difference in nausea or vomiting between groups.

Adolescent↗
PubMed2003

[The miraculous effects of taking laxatives. Success and failure of pre-modern medical treatment from the patients' perspective].

The massive use of laxatives, emetics and blood-letting in pre-modern medicine has often intrigued historians. Why did generations of prominent and often quite empirically minded physicians resort to methods which, in hindsight, were usually much more likely to do harm than good? And why did the patients not rebel?Based on patients' personal documents and, in particular, on the letter consultations many of them wrote ot renowned early modern physicians, this essay traces, how the sick and their relatives experienced and responded to this kind of treatment. These sources provide ample evidence, first of al, that early modern lay-men not only accepted evacuative treatment with laxatives and the like but often explicitly demanded it. To them these methods seemed plausible and indispensable in the light of their notions of disease causation. For diseases were generally though to result no so much from an imbalance of humours or qualities (as is often believed) but from a specific, impure, morbific matter which had to be expelled. And patients frequently felt better or even totally cured immediately after taking a drastic laxative. In hindsight, we may attribute this to a placebo effect or the self-limiting nature of most disease episodes. But in the patients' experience the efficacy of evacuative treatment was thus constantly reconfirmed. Indeed, the very physical perception of curative effects was already shaped by their deeply embodied belief in the predominantly humoural nature of human physiology and pathology, increasing the likelihood of placebo effects from treatment that occasioned a marked, clearing visible evacuation. Therapeutic failure, on the other hand, was a common experience, too, but it could easily be explained on a case to the case basis, as a result of divine will or, more commonly, of the physician's incompetence. Presumably he had not chose the right evacuative treatment or drug, which was adequate in the specific case and another physician with a slightly different approach might well have more luck. The beneficial effects of evacuative treatment as such, however, were not called into question. Treatment with laxatives, emetics and blood-letting thus became obsolete very gradually only, in the nineteenth century, when new, more solidistic body concepts started to prevail also among the population.

Bloodletting↗
PubMed2006

Chemotherapy-induced nausea and vomiting in acute leukemia and stem cell transplant patients: results of a multicenter, observational study.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in oncohematology in routine clinical practice, its impact on quality of life, and caregivers' perception of the extent of the problem. DESIGN AND METHODS: This was a multicenter, prospective, observational follow-up study including: (i) acute myeloid leukemia patients treated with moderately to highly emetogenic chemotherapy and (ii) hematopoietic stem cell transplant recipients, without reduced intensity conditioning. No exclusion criteria were applied. All patients received at least one 5-HT3 antagonist for emesis prophylaxis. Patients recorded emetic episodes and rated nausea daily. Quality of life was assessed through a validated functional living Index-Emesis questionnaire. A survey of caregivers' predictions of CINV was made and the predictions then compared with the observed CINV. RESULTS: One hundred consecutive transplant and 77 acute myeloid leukemia patients were studied. Transplant conditioning was the most important risk factor for CINV: complete response occurred in only 20% of transplant patients (vs. 47% for leukemia patients). Among patients with emesis, the mean percentage of days with emesis and the mean (+/-SD) total number of emetic episodes were 61% and 9.4+/-8.9 (transplant recipients), and 53.6% and 6.2+/-7.3 (leukemia patients), respectively. CINV control was lower in the delayed than in the acute phase. Antiemetic rescue therapy was ineffective. CINV had a deleterious effect on quality of life, especially among transplant recipients. Caregivers underestimated the incidence of delayed nausea and emesis in the transplant setting. INTERPRETATION AND CONCLUSIONS: Despite 5-HT3 antagonist prophylaxis, CINV remains a significant problem in oncohematology, especially in the delayed phase and in transplant recipients.

Acute Disease↗
PubMedDate not supplied

Dexamethasone effectively reduces postoperative nausea and vomiting in a general surgical adult patient population.

BACKGROUND: Postoperative nausea and vomiting (PONV) is still a common and major complication for surgical patients, which may delay post-anesthetic care unit discharge, prolong hospital stay and thus increase the cost of hospitalization. It is understood that PONV is a multi-factorial outcome and occurs more often with general anesthesia than with other anesthetic methods. Prophylactic administration of antihistamines, antidopaminergics, anticholinergics, phenothiazines, serotonin antagonist, steroids and even acupuncture has been shown to be effective. However, expenses and side effects of these agents have also been a concern for clinical doctors. The aim for this prospective study was to find an agent that is cost effective and side effect free (or at least with a low incidence of side effects) for the prevention of PONV. METHODS: A total of 700 adult surgical patients who planned to have surgery under general anesthesia were enrolled in this double-blinded, randomized and placebo-controlled study. Group P received the placebo (0.9% normal saline 2 ml) and Group D received 10 mg dexamethasone intravenously right before the induction of anesthesia. RESULTS: We found that during the postoperative period of 1-8 h, patients in Group D reported a lower incidence of PONV (24%) than those in Group P (39%, p < 0.001). Patients in Group D also requested less rescue anti-emetic (17%) than those in Group P (30%, p < 0.05). The same phenomenon was also noted in the 8-to-24-hour interval (PONV 4% vs. 12%, p < 0.05 and rescue anti-emetic 3% vs. 9%, p < 0.05 in Group D vs. Group P, respectively.) CONCLUSIONS: We conclude that the prophylactic intravenous administration of 10 mg dexamethasone immediately before the induction of anesthesia is effective in preventing PONV in the general surgical adult patient population.

Adult↗
PubMed2006

[Relationship between neurotransmitter blood noradrenalin and nausea/emesis after chemotherapy for lung cancer].

A clinical study was conducted to investigate the relationship between nausea/emesis after chemotherapy for lung cancer (docetaxel 60 mg/m(2), cisplatin 80 mg/m(2)) and blood serotonin (S), blood catecholamine (adrenaline) (A), noradrenaline (NA) and dopamine (D) in effective and non-effective patients treated with anti-emetic agents. All 37 patients received preventive combination administration of granisetron (GR) 3 mg, methylprednisolone 500 mg and metoclopramide (ME) 40 mg immediately before chemotherapy, followed by GR 3 mg and ME 40 mg on Day 2 and 3. Sixteen patients who were classified as emotionally unstable according to the YG character test additionally received prochlorperazine 15 mg thrice daily starting after their last meal prior to chemotherapy, until nausea/emesis disappeared. Blood concentration was measured on the day before chemotherapy and on Day 2, 4, and 14 after administration of the anticancer agents. As a result, a significant difference was demonstrated for NA on the day before chemotherapy (p<0.05), NA on Day 14 (p<0.01) and D on Day 14 (p<0.01) between effective and non-effective patients receiving anti-emetic treatment. In addition to conventional neurotransmitters S and D, NA is also worthy of attention in connection with nausea/emesis.

Antiemetics↗
PubMed2006

Effect of acupressure on nausea and vomiting induced by chemotherapy in cancer patients.

AIM: Corticosteroids, antidopaminergig agents and 5-HT3 antagonists are the most commonly used drugs in the treatment of chemotherapy-induced vomiting. Acupuncture and acupressure have also appeared to exert antiemetic effects. The aim of this study was to evaluate the efficacy of acupressure in the treatment of chemotherapy-induced vomiting resistant to the standard antiemetic therapies. METHODS: The study included 40 consecutive advanced cancer patients with untreatable chemotherapy-induced vomiting. Colorectal cancer, lung cancer and breast cancer were the neoplasm most frequent in our patients. According to tumour histotype, patients received chemotherapeutic regimens containing the main emetic cytotoxic agents, including cisplatin and athracyclines. Acupressure was made by PC6 point stimulation for at least 6 h/day at the onset of chemotherapy. RESULTS: The therapeutic approach was well accepted by the overall patients. An evident improvement in the emetic symptomatology was achieved in 28/40 (70%) patients, without significant differences in relation to neither tumor histotype, nor type of chemotherapeutic agent. CONCLUSIONS: This preliminary study seems to suggest that a bioenergetic approach by acupressure on PC6 point may be effective in the treatment of chemotherapy-induced vomiting resistant to the conventional pharmacological strategies, as previously demonstrated for vomiting occurring during pregnancy.

Acupressure↗
PubMed1991

Determinants of anticipatory nausea and anticipatory vomiting in adults receiving cancer chemotherapy.

There is a need for further empirical investigation of variables that may contribute to the occurrence of anticipatory nausea and/or anticipatory vomiting (AN/AV) in persons receiving cancer chemotherapy. The purpose of this study was to examine the relationship of AN/AV in adults receiving an initial course of cancer chemotherapy in an outpatient setting with the following set of variables: symptom distress, mood disturbance, stage of disease, sensitivity to conditioning cues, emetic potential of antineoplastic drugs, age, psychosocial stress, and ability to cope. Thirty-two percent of the sample developed anticipatory nausea. Multivariate statistics were used to examine the contribution of the variables to the prediction of AN/AV. Analysis of the data revealed that 53% of the variance accounted for was contributed by the following combination of variables: emetic potential of drug, level of symptom distress, mood disturbance, stress and ability to cope (p = .001). The total percentage of cases correctly classified was 88.3%. This combination of variables correctly classified 100% of patients who experienced anticipatory nausea (n = 15). Eighty-two percent of patients who did not experience anticipatory nausea and/or anticipatory vomiting (n = 28) were classified correctly.

Adaptation, Psychological↗
PubMed1991

Intramuscular injections through indwelling cannulae.

A study was performed to establish the feasibility of an indwelling intramuscular cannula for the administration of post-operative analgesic and anti-emetic medication. One-hundred cannulae were inserted for periods up to 7 days (mean = 2.4). A mean of five and maximum of 15 injections were made through each cannula with a maximum volume in any patient of 29 ml. On 18 occasions cannulae were removed for minor complications; no serious complications were seen. This technique may be useful for administration of intramuscular analgesic and anti-emetic medications in the post-operative period.

Adolescent↗
PubMed1991

Introduction: the clinical challenge.

In summary, ondansetron has proved to be a highly effective anti-emetric and is superior to metoclopramide in the treatment of acute emesis. The results in delayed emesis are less consistent, with superiority demonstrated in both non-cisplatin and radiotherapy studies, but rather equivocal results in cisplatin studies to date. Ondansetron exhibits minimal toxicity with no reported acute dystonic effects. This clearly is an obvious benefit - particularly in young patients. In three of the trials there was a crossover design which generated patient preference data (Table 5). Nausea and vomiting are very distressing but not life-threatening side effects; they are side effects to be tolerated by patients embarking on potentially curative chemotherapy. In the final analysis, patient preferences for a specific anti-emetic may well be one of the most important parameters by which a new anti-emetic should be judged. Since the London symposium, ondansetron has been introduced in the UK and New Zealand (Trademark ZOFRAN) and France (Trademark ZOPHREN). The objective of a satellite symposium to the 15th International Cancer Congress, Hamburg, held in August 1990, was to review new studies involving ondansetron and evaluate the clinical performance in a database of more than 5,500 cancer patients, including a significant paediatric contribution.

Antiemetics↗
PubMed1991

Progress in the control of acute and delayed emesis induced by cisplatin.

Ondansetron, a new 5-HT3 receptor antagonist, has been compared with high-dose metoclopramide in the control of acute emesis (24 h) induced by cisplatin (greater than or equal to 100 mg/m2). Ondansetron, given as three intravenous doses (0.15 mg/kg) 4-hourly, was superior to six intravenous doses of metoclopramide (2.0 mg/kg) in the control of acute emesis. Complete control of emesis was achieved in 40% of patients receiving ondansetron compared to 30% of patients receiving metoclopramide (P = 0.07); complete or major control (0-2 emetic episodes) was achieved in 65% and 51% of the patients receiving the two treatments respectively (P = 0.016). Patients entered in the acute emesis study who experienced no emesis or up to two episodes were randomised between placebo and ondansetron on day 2 to evaluate the control of delayed emesis up to day 5. Complete control of persistent or delayed emesis over days 2-5 was achieved in 59-78% of patients with oral ondansetron (16 mg t.d.s.) compared to 39-50% of patients receiving oral placebo. These differences failed to reach statistical significance except on day 4. Some patients with complete or major control of emesis on their first course of chemotherapy subsequently received further courses of ondansetron (median 3 courses; range 2-10) on a non-comparative basis. Similar control was achieved in 85% of courses. There may be some reduction in the degree of control with subsequent courses. Of 44 patients with complete control at cycle 1, 19 (44%) were emesis free and 3 (7%) experienced 1-2 episodes with cycle 3, though patients were sometimes withdrawn before cycle 3 for reasons other than inadequate anti-emetic control. Efficacy with successive courses can only be established in a prospective comparative trial. Both treatments were well tolerated but ondansetron caused significantly greater transient asymptomatic elevations in ALT/AST (P = 0.003/0.005). Acute dystonic reactions (2 patients) and akathisia (10 patients) occurred with metoclopramide only (P = 0.002). The role of ondansetron in the control of delayed emesis requires further study.

Akathisia, Drug-Induced↗