Ondansetron and dolasetron provide equivalent postoperative vomiting control after ambulatory tonsillectomy in dexamethasone-pretreated children

In this prospective, randomized, double-blinded, placebo-controlled study, we compared the incidence of emesis and 48-h recovery profiles after a single dose of preoperative ondansetron versus dolasetron in dexamethasone-pretreated children undergoing ambulatory tonsillectomy. One-hundred-forty-nine children, 2-12 yr old, ASA physical status I and II, completed the study. All children received standardized perioperative care, including premedication, surgical and anesthetic techniques, IV fluids, analgesics, and rescue antiemetic medications. Patients were randomized to receive ondansetron 0.15 mg/kg, maximum 4 mg (Group 1); dolasetron 0.5 mg/kg, maximum 25 mg (Group 2); or saline placebo (Group 3) IV before the initiation of surgery. In addition, all patients received dexamethasone 1 mg/kg (maximum 25 mg). Rescue antiemetics were administered for two or more episodes of retching/vomiting. The incidence of retching/vomiting before home discharge did not differ between the ondansetron and dolasetron groups and was significantly less frequent compared with the placebo group (10%, Group 1; 8%, Group 2; 30%, Group 3). Similar results were obtained at 24-48 h after discharge (6%, Groups 1 and 2; 18%, Group 3). The need for rescue antiemetics administered after the second retching/vomiting episode was significantly less in Groups 1 (4%) and 2 (6%) compared with Group 3 (22%) before home discharge. The complete response rate, defined as no retching/vomiting and no antiemetic for 48 h, was significantly increased in Groups 1 (76%) and 2 (74%) compared with Group 3 (44%). The antiemetic efficacy of prophylactic ondansetron and dolasetron was comparable in dexamethasone-pretreated children undergoing ambulatory tonsillectomy. IMPLICATIONS: The efficacy of a single dose of prophylactic ondansetron versus dolasetron in conjunction with dexamethasone was studied on posttonsillectomy retching/vomiting and 48-h recovery in children 2-12 yr old. Compared with placebo, ondansetron and dolasetron produced comparable reductions in the incidence of retching/vomiting and the need for rescue antiemetics.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

Background: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia.
Methods: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments: placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating of nausea severity, and total response (complete response with no nausea [≤ mm VAS]).
Results: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments.
Conclusion: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Dolasetron decreases postoperative nausea and vomiting after breast surgery

In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of dolasetron, dexamethasone, and metoclopramide in a preventing postoperative nausea and vomiting in women undergoing breast surgery. Patients were allocated randomly to one of four groups (20 patients each): group A received 12.5 mg dolasetron, group B received 8 mg dexamethasone, group C received 20 mg metoclopramide, and group D received placebo intravenously. If patients complained of retching or vomiting or if patients demanded an antiemetic, 1.25 mg droperidol was administered intravenously. To quantify postoperative nausea and vomiting, the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. Dolasetron and dexamethasone reduced the postoperative nausea and vomiting score significantly (p < 0.02 versus metoclopramide; p < 0.0001 versus placebo). Metoclopramide also reduced the postoperative nausea and vomiting score (p < 0.02 versus placebo). Fisher's exact test showed a significant reduction of vomiting in the dolasetron and dexamethasone groups compared with metoclopramide-treated patients (p < 0.007) and placebo-treated patients (p < 0.000006) and a significantly lower rate of nausea in comparison to the placebo group (p < 0.009). There were no significant differences between the metoclopramide and the placebo groups (using Fisher's exact test). The use of postoperative droperidol was significantly lower in both the dolasetron group (p < 0.04 versus metoclopramide; p < 0.0001 versus placebo) and dexamethasone group (p < 0.04 versus metoclopramide; p < 0.0001 versus placebo), as well as in the metoclopramide group (p < 0.02 versus placebo). Intravenous dolasetron and dexamethasone were equally effective and both are more effective than metoclopramide for preventing vomiting after breast surgery. Also both were significantly superior to either metoclopramide or placebo for postoperative nausea and vomiting and the need for droperidol rescue.     

Prophylactic anti-emetic efficacy of ondansetron in laparoscopic cholecystectomy under total intravenous anaesthesiaA randomised, double-blind comparison with droperidol, metoclopramide and placebo

The prophylactic anti-emetic efficacy and safety of pre-operative intravenous ondansetron was evaluated in a randomised, double-blind, comparison with droperidol, metoclopramide and placebo in 160 ASA grade 1 and 2 patients undergoing laparoscopic cholecystectomy under total intravenous anaesthesia. The patients were randomly allocated to receive ondansetron (4 mg), droperidol (1.25 mg), metoclopramide (10 mg) or placebo given as a single intravenous dose immediately before induction of a standardised general anaesthetic. There were no significant differences between the four study groups with regard to the demographic and anaesthetic data, postoperative analgesia, postoperative sedation scores, duration of postoperative hospital stay and incidence of adverse events. The incidence of nausea and vomiting was significantly lower (p < 0.05) between 1 h and 4 h after surgery in the ondansetron group compared with the droperidol, metoclopramide and placebo groups. The incidence of nausea was similar in the four groups in the other study periods: 0-1 h and 4-24 h. The incidence of vomiting was lower in the ondansetron, droperidol and metoclopramide groups than in the placebo group between 1 and 4 h but was the same between 4 and 24 h. As a result of the lower incidence of nausea and vomiting between 1 h and 4 h in the ondansetron group, the overall incidence of nausea and vomiting was lower during the first 24 h after surgery in this group than in the other three groups.     

Ondansetron disintegrating tablets of 8 mg twice a day for 3 days did not reduce the incidence of nausea or vomiting after laparoscopic surgery

BACKGROUND AND OBJECTIVE: Although many antiemetic drugs are available for intravenous use in the hospital setting, few are available after patient discharge. Consequently, nausea and vomiting are frequent complaints from patients at home after ambulatory surgery. We tested the hypothesis that the new 8 mg ondansetron disintegrating tablets will decrease the rate of nausea and vomiting at home after laparoscopic surgery. METHODS: Ninety-six patients were studied in a randomized double-blind study. Starting the first evening after operation and continuing every 12 h for 3 days, patients received either placebo or ondansetron 8 mg disintegrating tablets orally. The patients returned a questionnaire about postoperative nausea and vomiting, other side-effects, e.g. dizziness, headache, nightmare, anxiety and pain, as well as their overall satisfaction at 24 and 72 h after completion of surgery. RESULTS: The rates of nausea and vomiting were similar in the two groups, both during the first 24 h (28 versus 48%, placebo and ondansetron, respectively (ns) and during the 24-72 h (21 versus 35% (ns)). The incidence rate of vomiting was 8% (placebo) versus 12% (ondansetron) during the first 24 h (ns) and 9 versus 13% respectively in the 24-72 h (ns). No difference between groups was observed in overall satisfaction, incidence of postoperative pain or other side-effects. CONCLUSIONS: The use of ondansetron disintegrating tablets of 8 mg twice a day for 3 days did not reduce the incidence of nausea and vomiting in patients undergoing outpatient laparoscopic surgery.     

A comparison of the costs and efficacy of ondansetron and dolasetron in the prophylaxis of postoperative vomiting in pediatric patients undergoing ambulatory surgery

Postoperative vomiting (POV) after ambulatory surgery remains a major problem. We designed this study to determine the smallest dose of dolasetron equivalent to the Food and Drug Administration approved dose of ondansetron 100 micro g/kg IV, for the prophylaxis of POV in children undergoing surgery. In this double-blinded controlled study, 204 healthy ASA I-II children aged 2-12 yr, undergoing superficial ambulatory (day-case) surgery, were randomized to receive either ondansetron 100 micro g/kg IV, or dolasetron 45, 175, 350, or 700 micro g/kg IV during a standardized perioperative regimen. The primary end-point was the incidence of complete response, defined as the absence of POV symptoms. Costs were calculated from the perspective of the hospital using a previously described model. The incidence of early (0-6 h) and 24-h emesis was more frequent in the dolasetron 45 micro g/kg group compared with the dolasetron 350 and 700 micro g/kg groups and with the ondansetron group. Repeated POV occurred more often when dolasetron was used in a dose <350 micro g/kg. There were no significant differences in emesis rates between the dolasetron 175, 350, and 700 micro g/kg groups or between these groups and the ondansetron 100 micro g/kg group. The smallest dose of dolasetron with acceptable equivalent efficacy and patient satisfaction scores to ondansetron 100 micro g/kg was 350 micro g/kg. Institutional costs for managing POV were less with dolasetron 350 micro g/kg than with ondansetron. IMPLICATIONS: This randomized double-blinded dose-ranging study concluded that dolasetron, 350 micro g/kg IV, was the smallest dose that provided acceptable equivalent efficacy and patient satisfaction scores to ondansetron, 100 micro g/kg IV, for the prophylaxis of postoperative vomiting in children undergoing outpatient surgery. However, with this dose, the costs to the institution for managing postoperative vomiting were less.     

Ondansetron, orally disintegrating tablets versus intravenous injection for prevention of intrathecal morphine-induced nausea, vomiting, and pruritus in young males

In this study we compared the efficacy of orally disintegrating tablets (ODT) and IV ondansetron for preventing spinal morphine-induced pruritus and postoperative nausea and vomiting (PONV) in healthy young male patients. Patients who received bupivacaine with 0.20 mg morphine for spinal anesthesia were randomly assigned to the ODT group (ODT ondansetron 8 mg, n = 50), the IV group (4 mg ondansetron IV, n = 50), or the placebo group (n = 50). Each individual was assessed for pruritus, postoperative nausea and vomiting, and pain at 0, 2, 6, 12, 18, and 24 h after surgery using three distinct visual analog scales. The frequencies of postoperative nausea and vomiting and frequencies of requirement for rescue antiemetic and antipruritic were recorded. There were no significant differences among the three groups with respect to incidence or severity of PONV or postoperative pain visual analog scale scores. The incidences of pruritus in the ODT (56%) and IV (66%) groups were significantly different from that in the placebo group (86%) (P < 0.02 for both). Only the ODT group had significantly lower mean pruritus visual analog scale scores at 0, 2, 6, and 12 h postsurgery than the placebo group (P < 0.023 for all). The frequency of requirement for rescue antipruritic was significantly less in the ODT group than the placebo group (P = 0.013). Both ODT ondansetron 8 mg and IV ondansetron 4 mg are more effective than placebo for preventing spinal morphine-induced pruritus, but neither form of this agent reduces spinal morphine-induced postoperative nausea and vomiting in this patient group.     

The addition of antiemetics to the morphine solution in patient controlled analgesia syringes used by children after an appendicectomy does not reduce the incidence of postoperative nausea and vomiting

BACKGROUND: We studied the effect of intraoperative ondansetron 0.1 mg x kg(-1) or droperidol 0.01 mg.kg-1, followed by the same dose of the antiemetic agent added to the morphine solution during patient controlled analgesia (PCA) on the incidence of nausea and vomiting in children following an appendicectomy. METHODS: Sixty children, aged 5-13 years, were recruited and randomly allocated to receive no prophylactic antiemetic, the control group (group C), ondansetron (group O) or droperidol (group D). The PCA pump was programmed to deliver a bolus dose of 20 microg x kg(-1) of morphine.with a 5-min lockout period and a background infusion of 4 microg x kg(-1) x h(-1). RESULTS: Postoperatively, the three groups were compared for nausea, vomiting and sedation scores for 24 h. The incidence of postoperative nausea and vomiting was 33% for group C, 44% for group O and 41% for group D. There was no increase in sedation scores in the droperidol group. CONCLUSIONS: We were unable to show any significant benefit from the prophylactic administration of ondansetron or droperidol to children using morphine PCA devices following appendicectomy in the doses we employed.     

A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia

We assessed the efficacy and safety of ondansetron (0.1 mg/kg IV) prophylactically administered before surgery for prevention of postoperative vomiting (POV) in a double-blind, placebo-controlled study of 670 pediatric patients, 1- to 24-mo-old, undergoing elective surgery under general anesthesia. The study enrolled 335 children in each treatment group (ondansetron versus placebo). Significantly fewer children treated with ondansetron exhibited emesis or discontinued the study prematurely after surgery (ondansetron, 11%; placebo, 28%; odds ratio = 0.33; P < 0.0001). The number required to treat prophylactically with ondansetron to prevent POV was approximately six. Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21). The incidence of POV and other antiemetic effects of ondansetron were similar in children aged 1-12 mo and 13-24 mo and in children prospectively expected or not expected to require opioids as part of their anesthetic or analgesic management. Ondansetron was well tolerated; the incidence of adverse events considered possibly related to study drug was similar between treatment groups (ondansetron, 1.8%; placebo, 1.5%). IMPLICATIONS: This prospective, randomized, double-blind, placebo-controlled study establishes the efficacy and tolerability of IV ondansetron (0.1 mg/kg) in the prevention of postoperative emesis in 1- to 24-mo-old pediatric patients undergoing elective surgery under general anesthesia.     

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.     

Placebo-controlled comparison of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in patients undergoing hysterectomy

BACKGROUND AND OBJECTIVE: In a randomized, placebo-controlled, double-blind trial, we compared the efficacy of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in women undergoing hysterectomy. METHODS: Patients were allocated randomly to one of three groups: group A (n = 50) received 50 mg dolasetron orally, group B (n = 50) received 20 mg metoclopramide intravenously and placebo orally, group C (n = 50) received placebo orally. If patients complained of retching or vomiting, or if patients demanded an antiemetic, 1.25 mg droperidol was administrated intravenously. To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. The Raatz test was used to analyse postoperative nausea and vomiting (PONV) scores. RESULTS: Dolasetron reduced the postoperative nausea and vomiting score significantly (P < 0.02 vs. metoclopramide; P < 0.0001 vs. placebo). Metoclopramide also reduced the postoperative nausea and vomiting score (P < 0.02 vs. placebo). Fisher's exact test showed a significant reduction of vomiting in the dolasetron group compared with metoclopramide-treated patients (P < 0.007) and placebo-treated patients (P < 0.000006) and a significantly lower rate of nausea in comparison to the placebo group (P < 0.009). There were no significant differences between the metoclopramide and the placebo groups (in Fisher's exact test). The use of postoperative droperidol per patient was significantly lower in the dolasetron group (P < 0.04 vs. metoclopramide; P < 0.0001 vs. placebo) than in the metoclopramide (P < 0.02 vs. placebo) and in the placebo groups. CONCLUSIONS: Oral dolasetron is more effective than either metoclopramide given intravenously or placebo for preventing vomiting after hysterectomy. It also was significantly superior to either metoclopramide or placebo concerning the PONV score and the need for droperidol rescue.     

Preemptive antiemesis in patients undergoing modified radical mastectomy: oral granisetron versus oral ondansetron in a double-blind, randomized, controlled study

STUDY OBJECTIVE: To assess the efficacy of oral granisetron versus oral ondansetron for preemptive antiemesis in women undergoing modified radical mastectomy. DESIGN: Randomized, double-blind, controlled study. SETTING: Metropolitan hospital. PATIENTS: Ninety ASA physical status I and II hospitalized female patients, aged 18 to 65 y, scheduled for modified radical mastectomies. INTERVENTIONS: Patients were assigned to receive orally placebo, granisetron 2 mg, or ondansetron 4 mg (n = 30 in each group) 1 h before induction of anesthesia. A standard general anesthetic technique and postoperative analgesia were used. MEASUREMENTS: Postoperative nausea and vomiting and safety assessments were performed continuously 0 to 2, 2 to 6, 6 to 12, and 12 to 24 h after anesthesia. MAIN RESULTS: A complete response during 0 to 2 h after anesthesia was found in 43%, 63%, and 90% of patients who had received placebo, granisetron, or ondansetron, respectively; corresponding percentages of patients requiring rescue antiemetics were 40%, 17%, and 7%. Frequency of nausea and vomiting was low (less than 23%) after 2 h in the three groups. Observations of postoperative nausea and vomiting score and need for antiemetics at other time intervals (2 to 6, 6 to 12, and 12 to 24 h) were not significantly different among the three groups. CONCLUSION: Oral ondansetron 4 mg provided better preemptive antiemesis than oral granisetron 2 mg in the 2 h after modified radical mastectomy during general anesthesia.     

The efficacy of postoperative ondansetron (Zofran) orally disintegrating tablets for preventing nausea and vomiting after acoustic neuroma surgery

Postoperative nausea and vomiting is a frequent complication of craniotomy. We evaluated the ability of intraoperative IV ondansetron followed by postoperative ondansetron in an orally disintegrating tablet formulation to reduce the frequency and severity of postoperative nausea and vomiting in a prospective, randomized, placebo-controlled double-blind trial of 60 patients undergoing acoustic neuroma resection. Each patient received intraoperative ondansetron (4 mg IV) or placebo 30 min before case end. Postoperatively, patients received ondansetron in an orally disintegrating tablet formulation (8 mg BID) or placebo twice a day for up to 72 h. Metoclopramide was available as rescue therapy for both groups. Severity of nausea (as measured on a 10-cm visual scale), number of emetic episodes, and requirement for rescue therapy were recorded. In the immediate postoperative period, nausea severity was less in patients treated with ondansetron than placebo (3.3 +/- 4.1 versus 7.3 +/- 4.2; P < 0.001) and fewer patients experienced vomiting (3 of 28 versus 11 of 32; chi2 P < 0.01). More patients required some form of rescue treatment in the placebo group on the first postoperative day (26 of 32 versus 16 of 28; chi2 P < 0.01). We conclude that after acoustic neuroma surgery IV ondansetron treatment prevents immediate postoperative nausea and vomiting. Postoperative treatment with ondansetron in an orally disintegrating tablet formulation was associated with less frequent rescue therapy as compared with placebo on the first postoperative day.     

Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery

Background: The neurokinin₁ antagonist aprepitant is effective for preventionof chemotherapy-induced nausea and vomiting. We compared aprepitantwith ondansetron for prevention of postoperative nausea andvomiting. Methods: Nine hundred and twenty-two patients receiving general anaesthesiafor major abdominal surgery were assigned to receive a singlepreoperative dose of oral aprepitant 40 mg, oral aprepitant125 mg, or i.v. ondansetron 4 mg in a randomized, double-blindtrial. Vomiting episodes, use of rescue therapy, and nauseaseverity (verbal rating scale) were documented for 48 h aftersurgery. Primary efficacy endpoints were complete response (novomiting and no use of rescue therapy) 0–24 h after surgeryand no vomiting 0–24 h after surgery. The secondary endpointwas no vomiting 0–48 h after surgery. Results: Aprepitant at both doses was non-inferior to ondansetron forcomplete response 0–24 h after surgery (64% for aprepitant40 mg, 63% for aprepitant 125 mg, and 55% for ondansetron, lowerbound of 1-sided 95% CI > 0.65), superior to ondansetronfor no vomiting 0–24 h after surgery (84% for aprepitant40 mg, 86% for aprepitant 125 mg, and 71% for ondansetron; P< 0.001), and superior for no vomiting 0–48 h aftersurgery (82% for aprepitant, 40 mg, 85% for aprepitant, 125mg, and 66% for ondansetron; P < 0.001). The distributionof peak nausea scores was lower in both aprepitant groups vsondansetron (P < 0.05). Conclusions: Aprepitant was non-inferior to ondansetron in achieving completeresponse for 24 h after surgery. Aprepitant was significantlymore effective than ondansetron for preventing vomiting at 24and 48 h after surgery, and in reducing nausea severity in thefirst 48 h after surgery. Aprepitant was generally well tolerated.     

Dolasetron versus ondansetron for the treatment of postoperative nausea and vomiting

The management of postoperative nausea and vomiting (PONV) remains a persistent problem. Despite the use of prophylactic antiemetics, breakthrough nausea and vomiting still frequently occur. There have been no published studies comparing dolasetron and ondansetron for the treatment of PONV. This was a prospective, randomized, double-blind, active-controlled study in adult outpatient surgery patients. We screened 559 consecutive adult surgery patients, with 92 patients randomized to either ondansetron or dolasetron. The objectives of the study were 1) to determine whether treatment of PONV with ondansetron 4 mg IV or dolasetron 12.5 mg IV would result in better outcomes in patients undergoing day surgery and 2) to compare the cost of drugs used for treating PONV. Thirty-three (70%) of 47 patients given ondansetron required rescue medication, compared with 18 (40%) of 45 patients given dolasetron (P < 0.004). Dolasetron was approximately 40% less expensive than ondansetron, and the costs of the study drug plus rescue antiemetics were 30% less in the dolasetron group than in the ondansetron group. Dolasetron provided greater efficacy for antiemetic treatment because of the need for less rescue therapy. Because of the decreased use of rescue antiemetics and acquisition cost at our hospital, costs in the dolasetron group were less than costs in the ondansetron group.     

Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review

The role of dexamethasone in the prevention of postoperative nausea and vomiting (PONV) is unclear. We reviewed efficacy and safety data of dexamethasone for prevention of PONV. A systematic search (MEDLINE, EMBASE, Cochrane Library, hand searching, bibliographies, all languages, up to April 1999) was done for full reports of randomized comparisons of dexamethasone with other antiemetics or placebo in surgical patients. Relevant end points were prevention of early PONV (0 to 6 h postoperatively), late PONV (0 to 24 h), and adverse effects. Data from 1,946 patients from 17 trials were analyzed: 598 received dexamethasone; 582 received ondansetron, granisetron, droperidol, metoclopramide, or perphenazine; 423 received a placebo; and 343 received a combination of dexamethasone with ondansetron or granisetron. With placebo, the incidence of early and late PONV was 35% and 50%, respectively. Sixteen different regimens of dexamethasone were tested, most frequently, 8 or 10 mg IV in adults, and 1 or 1.5 mg/kg IV in children. With these doses, the number needed to treat to prevent early and late vomiting compared with placebo in adults and children was 7.1 (95% CI 4.5 to 18), and 3.8 (2.9 to 5), respectively. In adults, the number needed to treat to prevent late nausea was 4.3 (2.3 to 26). The combination of dexamethasone with ondansetron or granisetron further decreased the risk of PONV; the number needed to treat to prevent late nausea and vomiting with the combined regimen compared with the 5-HT3 receptor antagonists alone was 7.7 (4.8 to 19) and 7.8 (4.1 to 66), respectively. There was a lack of data from comparisons with other antiemetics for sensible conclusions. There were no reports on dexamethasone-related adverse effects. IMPLICATIONS: When there is a high risk of postoperative nausea and vomiting, a single prophylactic dose of dexamethasone is antiemetic compared with placebo, without evidence of any clinically relevant toxicity in otherwise healthy patients. Late efficacy seems to be most pronounced. It is very likely that the best prophylaxis of postoperative nausea and vomiting currently available is achieved by combining dexamethasone with a 5-HT3 receptor antagonist. Optimal doses of this combination need to be identified.     

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.     

Comparison of ondansetron, metoclopramide and placebo as premedicants to reduce nausea and vomiting after major surgery

In a randomised, double-blind study, we have compared the incidence of postoperative nausea and vomiting in 124 patients undergoing major lower limb orthopaedic surgery following oral premedication with temazapam and ondansetron 8 mg, metoclopramide 10 mg or placebo. They received a standardised epidural and general anaesthetic. An epidural mixture containing bupivacaine 0.1% and fentanyl 10 mg.ml⁻¹ was infused postoperatively. The occurrence of nausea and vomiting was assessed every 4 h for 24 h. The incidence of vomiting significantly decreased from 55% and 43% in the placebo and metoclopramide groups, respectively, to 26% in the ondansetron group (p = 0.03). The incidence of nausea and vomiting in patients who had previously suffered was also significantly reduced from 67% and 68% in the placebo and metoclopramide groups, respectively, to 29% in the ondansetron group (p = 0.035). We conclude that oral premedication with ondansetron 8 mg was superior to metoclopramide 10 mg and placebo in preventing postoperative nausea and vomiting following major orthopaedic surgery in patients given epidural opioid analgesia.     

A randomized, double-blinded comparison of ondansetron, droperidol, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy

Nausea or vomiting occurs frequently after craniotomy. Because of the need for frequent postoperative neurological assessment, an effective antiemetic with minimal sedative side effects is needed. Therefore, we compared ondansetron to droperidol in a randomized, double-blinded, placebo-controlled study. A total of 60 adults requiring elective supratentorial craniotomy received standardized IV anesthesia with 4 mg of ondansetron, 0.625 mg of droperidol, or placebo at skin closure. The incidence of postoperative nausea, emesis, pain and sedation scores, and rescue antiemetic use were recorded at 0, 0.5, 1, 4, 8, 12, 24, and 48 h. All groups were demographically similar. Differences existed for cumulative 8, 12, and 24 h incidences of nausea (24 h, P = 0.03) and emesis (24 h, P = 0.04). Within 4 h, when maximal effect could be expected from treatment, 20% of the ondansetron group, 25% of the droperidol group and 50% of the placebo group received rescue antiemetic (P = 0.12). No differences in pain (P = 0.82) or sedation (P = 0.74) scores were detected. Both ondansetron and droperidol prevent nausea; however, only droperidol reduces emesis after supratentorial craniotomy. The dose of droperidol used was not more sedating than ondansetron. Sustained reduction in nausea and emesis over 24 h indicates a preemptive benefit of prophylactic antiemetic in this surgical population. Implications: Nausea and vomiting after brain surgery are particularly troubling, because effective treatment may cause sedation, making postoperative neurological assessment difficult. Our study shows that both ondansetron and droperidol are effective in reducing nausea, and that droperidol is particularly effective in reducing vomiting. Neither drug caused more sedation than placebo.     

Scheduled prophylactic ondansetron administration did not improve its antiemetic efficacy after intracranial tumour resection surgery in children

BACKGROUND AND OBJECTIVE: Postoperative nausea and vomiting after craniotomy may increase intracranial pressure and morbidity in children. This prospective, randomized, placebo-controlled and double-blinded study was designed to evaluate the antiemetic efficacy of prophylactic ondansetron after intracranial tumour resections in children. METHODS: Ninety children were divided into three groups and received saline (Group 1), ondansetron 150 microg kg-1 intravenously at dural closure (Group 2) or two doses of ondansetron 150 microg kg-1 intravenously, the second dose repeated after 6 h (Group 3). Episodes of nausea, emesis and side-effects were noted for 24 h postoperatively. RESULTS: Overall 24 h incidence of postoperative nausea and vomiting was not significantly different among the three groups (9 (37.5%) in Group 1 vs. 7 (27%) in Group 2 and 8 (32%) in Group 3, P = 0.73). No difference in rescue antiemetic treatment or postoperative nausea and vomiting at specific time intervals (0-6 and 6-24 h postoperative period) was seen among the three groups. No significant side-effects were noted in any of the three groups. CONCLUSIONS: Ondansetron, in this study of 90 children, was not very effective in preventing nausea and vomiting after neurosurgical operations.