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PubMed2001

Prospective evaluation of antiemetic outcome following high-dose chemotherapy with hematopoietic stem cell support.

Considerable progress has been made in improving the control of chemotherapy-induced emesis. The impact of available antiemetic options for patients receiving stem cell transplants is unclear, as few prospective data have been collected. We prospectively evaluated antiemetic outcome in patients receiving stem cell transplantation over a 7-day period following the initiation of chemotherapy. The primary endpoints were the number of emetic episodes and the extent of nausea measured on a four-point scale. Eighty-two patients were evaluated. Ninety-five percent of patients had nausea during the first week of treatment; 80% had at least one emetic episode. The percentage of patients with emesis was as follows: day 1: 13%, day 2: 21%, day 3: 30%, day 4: 38%, day 5: 44%, day 6: 39%, day 7: 18%. In multivariate analysis, gender, emesis with prior chemotherapy, history of morning or motion sickness, type of transplant (auto vs allo), use of total body irradiation, or use of dexamethasone did not effect emesis control. Most patients receiving high-dose chemotherapy experience incompletely controlled emesis. Control of nausea and emesis progressively worsened with each subsequent day following initiation of chemotherapy, reaching a nadir on day 5. New treatment approaches are needed to improve emesis control in this patient population.

Adult↗
PubMed2002

Outcomes of antiemetic prophylaxis in children undergoing bone marrow transplantation.

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

Adolescent↗
PubMed2004

Granisetron vs ondansetron for prevention of nausea and vomiting in hematopoietic stem cell transplant patients: results of a prospective, double-blind, randomized trial.

The serotonin type-3 (5-HT3) antagonists represent a significant advance in the prevention of acute nausea and vomiting (N/V) from highly emetogenic chemotherapy. We sought to determine if any differences in efficacy or adverse effects exist between two such agents, ondansetron and granisetron, during conditioning therapy for hematopoietic stem cell transplantation (HSCT). Patients were randomized to receive either ondansetron 0.15 mg/kg intravenously every 8 h or granisetron 10 microg/kg intravenously daily. Additionally, all patients received scheduled dexamethasone and lorazepam. Prophylaxis was continued until 24 h after completion of chemotherapy. Nausea and distress were measured subjectively with visual analog scales and emetic episodes were quantified. Of the 110 randomized patients, 96 were evaluable for efficacy and safety. No significant differences in efficacy were observed between the ondansetron- and granisetron-treated patients, evaluated by comparing the degree of nausea and distress, number of emetic episodes and overall control of emesis. The adverse effects were also comparable and no patients were removed from study because of severe toxicities. This trial demonstrates that ondansetron and granisetron are equally effective at preventing acute N/V associated with conditioning therapy frequently used for HSCT. The agent of choice should be based on drug acquisition cost or preference.

Antiemetics↗
PubMed1997

Antiemetic activity of ondansetron in acute gastroenteritis.

BACKGROUND: The mechanism of nausea and vomiting associated with gastroenteritis is unknown. The role of 5-HT3 receptors in emesis associated with gastroenteritis was investigated in paediatric patients. METHODS: A randomized, double-blind, placebo-controlled, parallel-group study was conducted in three groups of 12 patients each, receiving either a single i.v. dose of ondansetron (0.3 mg/kg), metoclopramide (0.3 mg/kg) or placebo (sterile saline). Food was restricted and oral rehydration was administered for 4 h. RESULTS: During 0-24 h, the number of emetic episodes experienced was significantly greater (P = 0.048) with placebo (mean = 5) than ondansetron (mean = 2) and the proportion of patients experiencing no emesis was significantly greater (P = 0.039) with ondansetron (58%) than placebo (17%). A numerical difference, in favour of ondansetron, was observed between ondansetron and metoclopramide groups for both of the above parameters. Fewer treatment failures were observed with ondansetron (17%) than placebo (33%) and metoclopramide (42 %). More diarrheal episodes were observed in the groups receiving anti-emetic treatment. All three treatments were well tolerated. CONCLUSIONS: Ondansetron, a 5HT3 receptor antagonist, was significantly superior to placebo in preventing emesis associated with acute gastroenteritis, in paediatric patients. Therefore, serotonin, acting through 5HT3 receptors, may play a role in this form of emesis.

Acute Disease↗
PubMed2000

The effect of smoking on postoperative nausea and vomiting.

In an attempt to quantify the postoperative effects of smoking, 327 consecutive patients undergoing arthroscopic day case knee surgery were given a standard anaesthetic consisting of an intravenous induction with propofol and fentanyl followed by inhalational maintenance using isoflurane in an oxygen and nitrous oxide mixture. Pre-operatively, patients were asked inter alia to give details of social smoking habits. Postoperatively, patients were given standard analgesic and anti-emetic drugs. Prior to discharge patients were asked to give details of postoperative nausea and vomiting together with details of the severity of postoperative pain. There were 85 smokers and 242 nonsmokers. Of the 327 patients, a total of 42 (13%) complained of postoperative nausea and vomiting. Of the smokers, only 6% complained of postoperative nausea and vomiting in contrast to 15% of the nonsmokers (p < 0.05). It is postulated that enzyme induction is the most likely reason for this anti-emetic effect. Possible ways in which this clinically beneficial mechanism can be utilised to improve outcome after anaesthesia are discussed.

Adult↗
PubMed2001

Adenotonsillectomy in children: a comparison of morphine and fentanyl for peri-operative analgesia.

This study compared the effectiveness and side-effects of intra-operative fentanyl with fentanyl and morphine for elective adenotonsillectomy in a double-blind study, in 60 children randomly allocated to receive either intravenous fentanyl 1 microg x kg(-1) intra-operatively or intramuscular morphine 100 microg x kg(-1) at induction. All children received a standard anaesthetic induction with intravenous fentanyl 1 microg x kg(-1) and propofol 4-5 mg x kg(-1) and maintenance with oxygen, nitrous oxide and isoflurane. Pain scores, emetic episodes and supplemental morphine requirements were recorded for 24 h postoperatively. The overall incidence of postoperative vomiting was high in both groups: 70% in the fentanyl group and 78% in the morphine group. The incidence of postoperative vomiting was lower in the fentanyl group (p < 0.03) in the first 4 h, but similar by 24 h. Children who received morphine at any time in the first 24 h had more median (range) episodes of vomiting [2 (0-7)] than children receiving fentanyl only [l (0-3); p < 0.03]. Administration of rescue anti-emetics, pain scores in recovery and pain scores over the next 24 h were similar between the two groups.

Adenoidectomy↗
PubMed1997

Ondansetron is not superior to moderate dose metoclopramide in the prevention of post-operative nausea and vomiting after minor gynaecological surgery.

Peri-operative nausea and vomiting (PONV), remain a considerable problem. Ondansetron is being promoted currently as the drug of choice for the prevention and treatment of PONV. Experiments to investigate efficacy of ondansetron in PONV have been made with placebo or single doses of other drugs, e.g. metoclopramide, and often with different anaesthetic regimes with different emetic potential. This study investigated the relative benefits, in the prevention of PONV, of ondansetron compared with metoclopramide used at a dose higher than used in previous studies. Ninety-six patients undergoing minor gynaecological surgery were randomized to receive either ondansetron 4 mg or metoclopramide 0.4 mg kg-1. The patients were then assessed in the recovery room, in the day ward prior to discharge and the following day for the occurrence of PONV. Emetic symptoms occurred in similar proportions of patients who received ondansetron and metoclopramide. Nausea scores were similar between the groups in the recovery ward and 24-h follow-ups but there were higher post-operative nausea scores in the ondansetron group in the day ward (P = 0.001). There were no significant side effects due to either drug. We conclude that moderate dose metoclopramide is an effective alternative to ondansetron in the control of PONV.

Adult↗
PubMed1997

Double-blind comparison of alizapride, droperidol and ondansetron in the treatment of post-operative nausea.

To compare the efficacy in the treatment of post-operative nausea and/or vomiting (PONV), 75 patients undergoing gynaecological procedures under general anaesthesia using N2O/enflurane who suffered from PONV in the first hour after surgery were randomly allocated to three groups containing 25 patients each to receive either alizapride 100 mg, droperidol 1 mg or ondansetron 8 mg (i.v.). Patients expressed the severity of their nausea on a Visual Analogue Scale (VAS) ranging from 0 (none) to 10 (as bad as possible). Vomiting was recorded as present or absent, and the number of emetic events was noted. Data were recorded until rescue medication was given or until 4 h after the administration of the study drug. There were no significant differences between the three groups in the average VAS scores and the presence of vomiting at the time of entry into the study. Fifteen and 30 min after the administration of the study drug, VAS decreased notably in all groups. This decreases was similar and statistically significant within each group. However, comparison between the three groups showed no statistically significant differences. There was no statistically significant difference between the three groups in the number of patients receiving rescue medication, the number of emetic events and the time from administration of the study drug until rescue medication was given. It is concluded that alizapride 100 mg, droperidol 1 mg and ondansetron 8 mg intravenously are equally effective in the treatment of PONV after gynaecological procedures and that the newer drugs alizapride and ondansetron offer no advantage over droperidol.

Adolescent↗
PubMed1998

Addition of droperidol to morphine administered by the patient-controlled analgesia method: what is the optimal dose?

Eighty patients were recruited into a double-blind, randomized trial to find the optimal dose of droperidol for addition to the patient-controlled analgesia (PCA) morphine infusate for female patients undergoing gynaecological surgery. A standardized anaesthetic technique was employed. Post-operative analgesia was provided by PCA morphine. Patients were allocated at random into one of four treatment groups receiving with each PCA morphine bolus: (1) droperidol 0.05 mg; (2) droperidol 0.10 mg; (3) droperidol 0.15 mg; and (4) droperidol 0.20 mg, respectively. The incidence of post-operative nausea and vomiting (PONV), requests for rescue anti-emetic medication, and incidence of side effects were recorded. The number of symptom-free patients in each group increased as the droperidol dose increased, but although there was a significant inverse association between the total dose of droperidol received and the severity of PONV (P < 0.05), there were no significant differences between individual groups. In each group, patients were significantly less sedated at 24 h compared with 12 h (P < 0.01). However, after 24 h, patients in group 4 were significantly more sedated than patients in groups 1 and 2 (P < 0.05). There were no significant differences between the groups in terms of the incidence of anxiety or other side effects attributable to droperidol. The present authors suggest that, although the results demonstrate few statistically significant differences between the four groups, a PCA bolus dose of droperidol of 0.10 mg mL-1 appears to provide the optimal balance between anti-emetic efficacy and an acceptable incidence of side effects.

Adolescent↗
PubMed1999

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↗
PubMed1999

Prophylactic therapy with combined granisetron and dexamethasone for the prevention of post-operative vomiting in children.

This study was undertaken to compare the efficacy and safety of granisetron, a 5-hydroxytryptamine type 3 receptor antagonist, and dexamethasone and each drug alone for the prevention of post-operative vomiting by children, with no history of motion sickness and/or previous post-operative vomiting, undergoing general inhalational anaesthesia for surgery (inguinal hernia and phimosis). In a randomized, double-blind manner, 150 children, ASA physical status 1, aged 4-10 years, were assigned to receive granisetron 40 mg kg-1, dexamethasone 150 mg kg-1, or granisetron 40 mg kg-1 plus dexamethasone 150 mg kg-1 intravenously immediately after inhalation induction of anaesthesia (n = 50 of each). A complete response, defined as no emesis and no need for another rescue anti-emetic during the first 24 h after anaesthesia, was 86% with granisetron, 68% with dexamethasone and 98% with granisetron plus dexamethasone, respectively (P < 0.05; overall Fisher's exact probability test). No clinically serious adverse events were observed in any of the groups. In conclusion, prophylactic therapy with combined granisetron and dexamethasone was more effective than was each anti-emetic alone for the prevention of vomiting after paediatric surgery.

Anesthesia, Inhalation↗
PubMed1999

Prophylactic ondansetron for post-operative emesis: meta-analysis of its effectiveness in patients with and without a previous history of motion sickness.

The post-operative anti-emetic efficacy of 4 and 8 mg of ondansetron in adult patients with and without a previous history of motion sickness (PHMS) was assessed by meta-analysis. MEDLINE and EMBASE databases were searched for randomized placebo-controlled trials evaluating the anti-emetic effectiveness of ondansetron in a 24-h period. In the 49 studies found, a further selection was with respect to those studies that noted the patient's previous history of motion sickness. Twelve trials involving 2122 patients; 446 previous history of motion sickness(+) patients and 1676 previous history of motion sickness(-) patients met the selection criteria. The dose of 4 mg ondansetron was 71.5% more effective in previous history of motion sickness(+) than in previous history of motion sickness(-) patients. For the 8 mg dose, the odds ratios (95% CI) were: previous history of motion sickness(+) = 3.11 (1.40-6.93) and previous history of motion sickness(-) = 2.08 (1.35-3.21). The calculated number needed to treat was also more favourable in previous history of motion sickness(+) patients for both doses of ondansetron, demonstrating a higher effectiveness in this subgroup of patients.

Antiemetics↗
PubMed1999

Ondansetron is more effective than metoclopramide for the treatment of opioid-induced emesis in post-surgical adult patients. Ondansetron OIE Post-Surgical Study Group.

Nausea and vomiting are common side effects of opioids administered for pain control. This double-blind, randomized, parallel-group study evaluated the anti-emetic efficacy and tolerability of single intravenous (i.v.) doses of ondansetron 8 mg, ondansetron 16 mg and metoclopramide 10 mg in the treatment of opioid-induced emesis. Adult patients undergoing low emetogenic surgical procedures, using a standardized anaesthesia regimen were assessed for 24 h following administration of study anti-emetic to treat established post-surgical opioid-induced emesis. A total of 4511 patients were enrolled of whom 1366 experienced opioid-induced emesis and received randomized study medication. Ondansetron 8 mg and 16 mg were significantly better than metoclopramide 10 mg (P < 0.05) for both complete control of emesis, complete control of nausea and other efficacy measures. There were no significant differences between the two ondansetron groups. All three treatments were well tolerated. In conclusion, this large, multicentre study demonstrates that ondansetron is more effective than metoclopramide in the treatment of opioid-induced emesis following administration of post-surgical opioids to control pain.

Adolescent↗
PubMed1999

Prevention of post-operative nausea and vomiting with combined granisetron and droperidol in women undergoing thyroidectomy.

We have compared the efficacy and safety of combined granisetron and droperidol with each anti-emetic alone for preventing post-operative nausea and vomiting after thyroidectomy. In a prospective, randomized, double-blind study, 180 women received granisetron 40 micrograms kg-1, droperidol 20 micrograms kg-1, or granisetron 40 micrograms kg-1 plus droperidol 20 micrograms kg-1 (n = 60 of each) intravenously immediately before induction of anaesthesia. A standard general anaesthetic technique and post-operative analgesia were used. A complete response, defined as no post-operative nausea and vomiting and no need for another rescue anti-emetic, during the first 24 h after anaesthesia occurred in 88%, 60% and 98% of patients who had received granisetron, droperidol and granisetron plus droperidol (P < 0.05; overall Fisher's exact probability test). No clinically important adverse events due to the drugs were observed in any of the groups. In summary, prophylactic use of combined granisetron and droperidol is more effective than each drug alone for the prevention of post-operative nausea and vomiting in female patients undergoing thyroidectomy.

Adult↗
PubMed1999

Assessment of ondansetron and droperidol for the prevention of post-operative nausea and vomiting after cholecystectomy and minor gynaecological surgery performed by laparoscopy.

The anti-emetic effects of ondansetron and droperidol were evaluated in 134 ASA Grade I and II female patients, scheduled for laparoscopic cholecystectomy and minor gynaecological laparoscopic surgery, who were randomly assigned to receive ondansetron 4 mg or droperidol 75 micrograms kg-1 intravenously immediately after induction of anaesthesia. The patients were assessed 1, 6, 12 and 24 h after surgery for intensity of nausea and number of vomiting episodes. In the case of the patients undergoing laparoscopy, vomiting episodes occurred in a similar proportion in patients treated with ondansetron or droperidol, with the probability of the Type I error of 0.05 and the Type error II of 0.1. Although there was no difference between the two groups in emetic episodes following all laparoscopic procedures and gynaecological laparoscopic surgery, there was a significant difference between these parameters after laparoscopic cholecystectomy. The patients treated with ondansetron experienced a lower intensity of nausea (P = 0.04) after laparoscopic cholecystectomy, less frequent severe nausea (P = 0.02) and episodes of vomiting (P = 0.04) when compared with those in the droperidol group. We conclude, that despite the result the droperidol prophylaxis appears to be an effective alternative to ondansetron in all patients undergoing laparoscopy, the ondansetron prophylaxis is superior to droperidol in patients undergoing laparoscopic cholecystectomy.

Adult↗
PubMed2000

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↗
PubMed2002

Control of nausea and vomiting after chemotherapy: what is the evidence?

The control of nausea and vomiting is an important problem for patients undergoing chemotherapy. With the introduction of newer agents, including 5-HT3 antagonists, nausea and vomiting control after chemotherapy has much improved but is not always optimal. While there is an intrinsic limitation to the efficacy of anti-emetic drugs, their efficacy can be further reduced if the drugs are not used appropriately. In some circumstances newer anti-emetics may be unnecessary and better nausea and vomiting control may be established by use of older agents. This paper summarizes current evidence regarding the optimal approach to management of nausea and vomiting in patients undergoing chemotherapy.

Antiemetics↗
PubMed1997

Ondansetron reduces nausea and vomiting after paediatric adenotonsillectomy.

The efficacy, safety and resource implications of a single intravenous dose of ondansetron (0.1 mg.kg-1, maximum 4 mg) were assessed in a multinational, multicentre, randomized, double-blind, placebo-controlled trial of 427 children aged 1-12 years, undergoing tonsillectomy with/without adenoidectomy. Emesis (retching and/or vomiting) and nausea were analysed separately. Significantly more ondansetron-treated children had no episodes of emesis (127/212 (60%) vs 100/215 (47%); P = 0.004) and experienced no postoperative nausea (135/211 (64%) vs 108/213 (51%); P = 0.004) in the first 24 h. Ondansetron also reduced the number of emetic episodes (P < 0.001), the time to the first emetic episode (P < 0.001) and overall nausea severity (P = 0.003). Significantly fewer ondansetron-treated children were rescued or withdrawn from the study (5% vs 10%; P = 0.042). Fewer ondansetron-treated patients required nursing intervention (34% vs 45%; P = 0.007) and the average intervention time was significantly shorter (4.6 vs 8.1 minutes; P = 0.001). Resources used to manage PONV were significantly reduced by ondansetron (43% vs 57%; P = 0.014).

Adenoidectomy↗