Ondansetron dose response curve in high-risk pediatric patients

Study Objective: To establish a dose-response relationship for ondansetron, and to evaluate any effects of oral premedication with metoclopramide in pediatric patients undergoing tonsillectomy and adenoidectomy and strabismus surgery.

Design: Prospective, randomized, double blind study.

Setting: University affiliated, 280-bed pediatric hospital.

Patients: 320 ASA physical status I and II patients between the ages of 2 and 12 years undergoing tonsillectomy and adenoidectomy or strabismus surgery.

Interventions: Patients were randomized to eight investigational groups. Patients in all eight groups underwent a standard anesthetic. Groups 1, 2, 3, and 4 received intravenous (IV) saline or IV ondansetron at doses of 0.05 mg/kg, 0.1 mg/kg and 0.15 mg/kg, respectively. Groups 5, 6, 7, and 8 received oral metoclopramide 0.15 mg/kg as well as IV saline, and ondansetron 0.05 mg/kg, 0.1 mg/kg, or 0.15 mg/kg. Patients were evaluated for emetic episodes prior to and following discharge.

Measurements and Main Results: All doses of ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg were significantly more effective than placebo in reducing the incidence of emesis prior to, following discharge, and during the first 24 postoperative hours (p < 0.001). There were no significant differences in the occurrence of emesis between the groups receiving ondansetron 0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg. The addition of oral metoclopramide 0.15 mg/kg had no effect on the incidence of emesis in the ondansetron or placebo study groups.

Conclusions: Ondansetron is an effective medication for the treatment and prevention of postoperative nausea and vomiting, and a dose of ondansetron 0.05 mg/kg is as effective as 0.1 mg/kg and 0.15 mg/kg. Metoclopramide 0.15 mg/kg has no effect on the incidence of postoperative nausea and vomiting.     

Ondansetron versus dehydrobenzoperidol and metoclopramide for management of postoperative nausea in laparoscopic surgery patients.

BACKGROUND: In this prospective, randomized, double-blind study, we compared the efficacy of ondansetron versus dehydrobenzoperidol (droperidol) or metoclopramide in the treatment of established postoperative nausea and vomiting in 200 adult patients undergoing laparoscopic surgery under general anesthesia. METHODS: One hundred seventy-three American Society of Anesthesiologists (ASA) I and II patients satisfied inclusion criteria. Fifty-seven patients received ondansetron 4 mg (group O), 57 patients were given droperidol 1.25 mg (group D), and 59 patients received metoclopramide 10 mg (group M). Antiemetic efficacy was compared at 10 minutes and 30 minutes after the administration of the study drug. RESULTS: At 10 minutes, nausea scores in group O dropped from 8.3 to 3.7, in group D from 8.5 to 5, and in group M from 8.4 to 6.7; (P < 0.05 between the three groups). At 30 minutes, nausea scores were 1.3 in group O, 1.7 in group D, and 5 in group M; (P < 0.05 between group M and the other two groups). In the droperidol group, 25% of patients developed sedation. Patient satisfaction was best with ondansetron. CONCLUSIONS: Both ondansetron and droperidol were more effective in the treatment of established postoperative nausea and vomiting than was metoclopramide. However, patients were satisfied best with ondansetron, which acts faster and causes less sedation than droperidol.     

Prevention of emesis in 1-day ophthalmic surgery: double-blind comparison of ondansetron, droperidol and placebo

In a randomized, double-blind study, we compared the prophylactic efficacy of ondansetron at a dose of 0.1 mg/kg (OND) vs. droperidol at a dose of 0.075 mg/kg (DBP) vs. placebo (PLA) in 120 patients undergoing pediatric 1-day ophthalmic surgery. Results showed an incidence of emesis in 10% of the OND group, in 37.5% of the DBP group and in 65% of the PLA group. Prophylactic administration of ondansetron represents the anti-emetic agent of choice in pediatric 1-day ophthalmic surgery.     

Ondansetron in the treatment of postoperative vomiting: a randomized, double-blind comparison with droperidol and metoclopramide.

The prophylactic antiemetic efficacy of ondansetron was evaluated in a randomized, double-blind comparison with droperidol and metoclopramide in 66 patients undergoing general anesthesia for dilatation and curettage. Ten minutes before induction of anesthesia, 22 patients received a single intravenous dose of 8 mg of ondansetron, 22 others received 1.25 mg of droperidol, and the remaining 22 received 10 mg of metoclopramide. Anesthesia was induced with 3.3-5 mg/kg of intravenous thiopental and maintained with 65% nitrous oxide in oxygen and 2%-3% enflurane. Postoperatively, the incidence of vomiting was 13% with ondansetron, 45% with droperidol, and 54% with metoclopramide (P less than 0.05; overall chi 2 test). There was no statistically significant difference in the incidence of nausea among the groups. Postoperative sedation and well-being scores were not significantly different among the groups. We conclude that preoperative prophylactic administration of ondansetron is superior to droperidol or metoclopramide in the prevention of emetic sequelae after general anesthesia for dilatation and curettage.     

Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting

We have studied 746 males and females undergoing general anaesthesia for any type of surgical procedure in a double-blind, controlled, randomized study. After experiencing at least one nausea and/or one emetic episode in the 6 h after recovery from anaesthesia, patients received either ondansetron 4 mg i.v. or metoclopramide 10 mg i.v. Patients were observed for postoperative nausea and vomiting (PONV) for 24 h after drug administration. Complete control of PONV was achieved more frequently in the ondansetron-treated patients compared with the metoclopramide-treated patients during the 24-h period (59% vs 41% (P < 0.001) and 44% vs 34% (P = 0.006) for emetic episodes and nausea, respectively). Furthermore, ondansetron was associated with greater patient satisfaction than metoclopramide (P < 0.001) with 49% and 32% of patients, respectively, very satisfied. The overall incidence of adverse events was similar in the ondansetron (7%) and metoclopramide (8%) groups. Ondansetron was as well tolerated and more effective than metoclopramide for all assessment criteria in the treatment of established PONV.      

Comparison of Acustimulation and Ondansetron for the Treatment of Established Postoperative Nausea and Vomiting

Background: This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand(R) compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery.

Methods: After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand(R); (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand(R); and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand(R). A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery.

Results: The combination group had a significantly higher complete response rate than the acustimulation group (73%vs. 40%, P < 0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P < 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores.     

A singleiv dose of ondansetron 8 mg prior to induction of anaesthesia reduces postoperative nausea and vomiting in gynaecological patients

The effect of a single intravenous dose of ondansetron in preventing postoperative nausea and emesis (retching and vomiting) (PONV) was investigated in a randomized, double-blind, placebo-controlled, multicentre, international study. Women of ASA class I–III, requiring gynaecological laparotomy, vaginal hysterectomy, or major vaginal surgery were selected for study. Two hundred and thirty-five received placebo, 231 received 1 mg ondansetron, 228 received 8 mg ondansetron and 229 received 16 mg ondansetron, as an infusion over five minutes before the induction of anaesthesia. A standardized balanced anaesthetic technique was employed. This consisted of premedication with either diazepam or temazepam, thiopentone induction, maintenance with nitrous oxide in oxygen supplemented with enflurane or isoflurane, intraoperative analgesia with fentanyl, neuromuscular blockade with any choice of agent and reversal with neostigmine and atropine. Postoperative analgesia was achieved with morphine, and prochlorperazine or metoclopramide were given if a rescue antiemetic was required. A greater percentage of patients in the 8 mg and 16 mg ondansetron groups experienced no postoperative emesis (44% and 39% respectively) than in the placebo and 1 mg ondansetron groups (29% and 28% respectively) for the first 24 hr postoperative period (8 mg vs placebo and 1 mg: P ≤ 0.001; 16 mg vs placebo: P < 0.05; 16 mg vs 1 mg: P < 0.05). Similarly, the percentage of patients who did not experience postoperative nausea were 20%, 26%, 31% and 28% for the placebo, 1 mg, 8 mg and 16 mg ondansetron treatment groups, respectively (8 mg and 16 mg vs placebo P < 0.05). Overall, the incidences of adverse events in the ondansetron and placebo groups were similar. It is concluded that intravenous ondansetron, at doses of 8 mg and 16 mg, is both well tolerated and effective in preventing postoperative nausea and emesis, and no greater benefit was observed with the 16 mg dose in comparison with the 8 mg dose.     

Ondansetron oral disintegrating tablets: acceptability and efficacy in children undergoing adenotonsillectomy

Postoperative nausea and vomiting (PONV), a major complication in children, is responsive to IV and oral ondansetron. Because these routes are not always available, we studied the acceptability and efficacy of ondansetron oral disintegrating tablets (ODT). In this double-blind, randomized, placebo-controlled study, 62 patients undergoing adenotonsillectomy, aged 5 to 11 years, preoperatively received ODT (4 mg) or placebo. Patients assessed the medication for taste and sensation. Anesthesia was induced with sevoflurane, maintained with desflurane, and supplemented with fentanyl 2.5 microg/kg and dexamethasone 0.5 mg/kg (maximum dose, 12 mg). An observer blinded to treatment evaluated patients for pain, agitation, and PONV. Postoperative treatment consisted of fentanyl 1 microg/kg for pain and agitation and metoclopramide 0.15 mg/kg (maximum dose, 10 mg) for PONV. There were no significant differences between study groups with regard to age, weight, recovery time, agitation, or pain. Approximately 90% of the subjects found the ODT to taste good. No subject rejected the study medication, but the ondansetron-containing tablets were found to be less palatable than the placebo. The incidence of vomiting was significantly less in the ondansetron-medicated group.     

Comparison of anti-emetic effects of ondansetron, metoclopromide or a combination of both in children undergoing surgery for strabismus

This prospective, randomized and double-blinded study was designed to evaluate the anti-emetic efficacy of a combination of ondansetron and metoclopramide in 100 ASA physical status I and II children of either sex and 1-15 years of age undergoing elective surgery for strabismus. A standardized anaesthetic technique and post-operative analgesia were used for all the children. Children were divided into four groups. They received saline, metoclopromide 250 micrograms kg-1, ondansetron 150 micrograms kg-1 or a combination of metoclopramide 150 micrograms kg-1 and ondansetron 100 micrograms kg-1 intravenously immediately after the insertion of an intravenous cannulae. There were no differences between the groups in their age, gender, weight, duration of surgery, number of muscles subjected to surgery or intravenous fluids received. In the first 24 post-operative hours, 18 (72%) patients in the placebo group, 15 (60%) patients in the metoclopramide group, 10 (40%) patients in the ondansetron group and 11 (44%) patients in the combination group had nausea or vomiting. The overall incidence of post-operative nausea and vomiting was significantly (P < 0.05) lower in the combination group and in the ondansetron group compared with the placebo group. Nine (36%) patients in both the placebo and the metoclopramide groups and one (4%) patient in the ondansetron group required rescue anti-emetic treatment. None of the patients in the combination group required rescue anti-emetic and this was significantly less (P < 0.01) when compared with the placebo and the metoclopramide groups. Recovery and sedation scores were comparable in all the four groups. A combination of metoclopramide 150 micrograms kg-1 and ondansetron 100 micrograms kg-1 administered prior to surgery was not found to be more effective than ondansetron 150 micrograms kg-1 alone for the prophylaxis of nausea and vomiting following surgical repair of strabismus in paediatric patients.     

Post-Laparoscopic Vomiting in Females versus Males: Comparison of Prophylactic Antiemetic Action of Ondansetron versus Metoclopramide

Background and Objectives:

The incidence of postoperative vomiting in patients undergoing laparoscopic cholecystectomy is compared in females versus males. The report also compares the prophylactic action of ondansetron versus metoclopramide.

Methods:

A total of 85 American Society of Anesthesiologists (ASA) I and II patients were enrolled in the study. Patients were divided into two groups according to sex: Group I 53 females, and Group II 32 males. After anaesthetic induction, subjects received intravenously either 4 mg ondansetron or 10 mg metoclopramide.

Results:

The incidence of vomiting as well as the frequency of emetic episodes over 24 hours were analyzed in each group using X2 analysis. Data analysis revealed a significantly higher incidence (P<0.05) of postoperative emesis in females 10:53 (18.9%) as compared to males 0:32 (0%). In the male group, no patient vomited postoperatively, whether prophylactic ondansetron or metoclopramide was used. While the incidence of emesis in the female group was lower (P<0.05) in the ondansetron group (17.6%) than the metoclopramide group (29.6%).

Conclusion:

These results may indicate prophylactic antiemetic therapy in female patients undergoing laparoscopic cholecystectomy; ondansetron appears to be superior to metoclopramide.     

预防性给于恩丹西酮可以降低蛛网膜下腔注入阿片药所致瘙痒的发生

目的:观察预防性静脉给与恩丹西酮对蛛网膜下腔芬太尼和吗啡所致瘙痒的作用。方法:随机选择ASA Ⅰ～Ⅱ级拟行下肢和下腹部手术的病人240例,按双盲原则分为OBM、OBF、BM和BF4组,所有病人均采用蛛网膜下腔重比重液布比卡因麻醉,在蛛网膜下腔注入布比卡因和吗啡或芬太尼前,随机静脉给与恩丹西酮8mg或生理盐水。蛛网膜下腔注药后分别于15min、30min、45min、60min及1h、2h、3h、4h、5h和6h对病人进行瘙痒情况评估。采用x~2和q检验进行统计学分析。结果:生理盐水组(BM和BF)瘙痒发生率明显高于恩丹西酮组(OBM和OBF)(P<0.05和P=0.001)。四组病人瘙痒发生时间和持续时间相似(P>0.05)。结论:预防性给与恩丹西酮可以降低吗啡、芬太尼和布比卡因蛛网膜下腔注射引起的瘙痒的发生,对芬太尼组效果更为显著。     

L'ondansétron oral réduit-il l'incidence des nausées et vomissements après chirurgie du strabisme chez l'enfant ?

ObjectiveTo compare the efficacy of oral ondansetron with oral metoclopramide for the prevention of postoperative vomiting and nausea in children undergoing strabismus surgery.Study designProspective, randomized, double-blind trial.PatientsThirty children of physical class 1, age 9 ± 4 years, scheduled for strabismus surgery, were randomized into two groups (ondansetron and metoclopramide).MethodsIn the ondansetron group, the children received the first oral dose of ondansetron (4 mg) 1 hour before induction of anaesthesia and the other doses 8 and 16 hours later. In the metoclopramide group, children received metoclopramide (5 mg) in the same conditions. Anaesthesia was induced with thiopentone, vecuronium and fentanyl and maintained with halothane and N₂O/O₂. Patients were evaluated by an independent observer for nausea and emesis in recovery room (0–2 h) and on the ward. The adverse effects of oral ondansetron and metoclopramide were assessed.ResultsThere were non-significant differences between the two groups for incidence of nausea and vomiting (40% and 53% in ondansetron group versus 33 and 60% in metoclopramide group, respectively).ConclusionUnlike intravenous ondansetron, oral ondansetron is not superior to metoclopramide for the prevention of nausea and vomiting caused by strabismus surgery in children.     

Intravenous Ondansetron in Established Postoperative Emesis in Children

Background: In pediatric postsurgical patients, postoperative vomiting is a common occurrence that can delay recovery and result in unplanned hospital admissions after outpatient surgery. This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of ondansetron in the control of established postoperative emesis in outpatients aged 2-12 yr.

Methods: Screened for the study were 2,720 ASA physical status 1-3 children undergoing outpatient surgery during general anesthesia, which included nitrous oxide. Children experiencing two emetic episodes within 2 h of discontinuation of nitrous oxide were given intravenous ondansetron (n = 192; 0.1 mg/kg for children weighing less or equal to 40 kg; 4 mg for children weighing > 40 kg) or placebo (n = 183).

Results: The proportion of children with no emetic episodes and no use of rescue medication was significantly greater (P < 0.001) in the ondansetron group compared with placebo for both 2- and 24-h periods after study drug administration (78% of the ondansetron group and 34% of the placebo group for 2 h; 53% of the ondansetron group and 17% of the placebo group for 24 h). Among patients with at least one emetic episode or with rescue medication use, the median time to onset of emesis or rescue was 127 min in the ondansetron group compared with 58 min in the placebo group (P < 0.001). The median time from study drug administration until discharge was significantly shorter (P < 0.01) in the ondansetron group (153 min, range 44-593 min) compared with the placebo group (173 min, range 82-622 min). The incidence of potentially drug-related adverse events was similar in the ondansetron (3% of patients) and the placebo (4% of patients) groups.     

Ondansetron versus metoclopramide in prophylaxis of nausea and vomiting for laparoscopic cholecystectomy: a prospective double-blind randomized study

OBJECTIVE: Patients who undergo laparoscopic cholecystectomy may be at risk of experiencing postoperative nausea and vomiting. This prospective, randomized, double-blind study compared the prophylactic use of metoclopramide and ondansetron for the treatment of postoperative nausea and vomiting in patients who underwent elective laparoscopic cholecystectomy. METHODS: Eighty patients were randomized into two groups. Patients received ondansetron 4 mg or metoclopramide 10 mg intravenously in a double-blind manner at the end of anaesthesia. RESULTS: The incidence of nausea was 45% for metoclopramide and 20% for ondansetron in the 24 hours postoperatively; the difference was statistically insignificant (p = 0.05). Postoperative nausea score did not show any significant difference between the two group in the first 2 hours (p = 0.3) and 4 hours (p = 0.12) but was significant between 4 and 24 hours (p = 0.02). The incidence of vomiting was 20% for metoclopramide and 2.5% for ondansetron. This difference was statistically significant (p = 0.02). CONCLUSION: Ondansetron 4 mg given intravenously at the end of surgery is effective for preventing vomiting after laparoscopic cholecystectomy.     

Efficacy of ondansetron and metoclopramide for preventing postoperative emesis following strabismus surgery in children

A double-blind, randomised, placebo-controlled trial was conducted to compare the efficacy of metoclopramide with the 5-HT₃ antagonist, ondansetron, for the prevention of postoperative emesis in children undergoing elective strabismus surgery. None of the children received any premedication and a similar anaesthetic technique was used for all. Ondansetron 0.15 mg.kg⁻¹, metoclopramide 0.25 mg.kg⁻¹ or saline placebo were administered following intravenous catheter placement. Episodes of emesis were recorded for the first 24 h for the intervals of 0–2, 2–6 and 6–24 h. The incidence of emesis in the first 24 h was observed to be 71.7% in the placebo group, 34.4% in the ondansetron group (p < 0.001) and 61.4% in the metoclopramide group (p = NS). The severity of vomiting was less in the ondansetron group as compared with metoclopramide (p < 0.01) and placebo (p < 0.001). Recovery room scores were comparable in all the groups. No serious side-effects were observed in the ondansetron group. We conclude that prophylactic ondansetron is effective and superior to metoclopramide in the prevention of postoperative emesis in children following elective strabismus surgery.     

The effectiveness of rescue antiemetics after failure of prophylaxis with ondansetron or droperidol: a preliminary report

STUDY OBJECTIVES: To compare the effectiveness of treating established postoperative nausea and vomiting (PONV) with an antiemetic acting at a different receptor with that of treating PONV with the antiemetic used for prophylaxis. DESIGN: Analysis of data collected in a previously published randomized, double-blind, placebo-controlled study. SETTING: Outpatient surgical procedures from 50 institutions in North America. PATIENTS: Patients (N = 2061) undergoing outpatient surgical procedures planned to last no more than 2 hours. INTERVENTIONS: Patients were randomized to receive ondansetron 4 mg, droperidol 1.25, droperidol 0.625 mg, or placebo. In the postoperative anesthesia care unit, patients who developed PONV received rescue antiemetics at the discretion of the attending anesthesiologist. The following antiemetics were used for rescue: ondansetron 4 mg, droperidol 0.625 to 1.25 mg, metoclopramide 10 mg, promethazine 6.25 to 25 mg, and dimenhydrinate 25 to 50 mg. MEASUREMENTS: The complete response rate (no nausea, no emesis, and no need for further rescue) after administration of the rescue antiemetic in patients with established PONV was calculated. The complete response rate after administration of each of the different rescue antiemetics was compared with that after administration of the same antiemetic used for PONV prophylaxis. MAIN RESULTS: In patients who failed prophylaxis with ondansetron 4 mg, the complete response rate was significantly higher (P = .02) after rescue with promethazine 6.25 to 25 mg (78%) than after rescue with ondansetron 4 mg (46%). In patients who failed prophylaxis with droperidol 0.625 and 1.25 mg, the complete response rate was significantly higher after rescue with promethazine 6.25 to 25 mg (77%; P = .02) and dimenhydrinate 25 to 50 mg (78%; P = .04) than after rescue with droperidol 0.625 to 1.25 mg (56%). CONCLUSION: In patients who failed prophylaxis with ondansetron or droperidol, promethazine was significantly more effective than the agent used for prophylaxis for the treatment of PONV. In patients who failed prophylaxis with droperidol, dimenhydrinate was also more effective than droperidol for the treatment of established PONV in the postoperative anesthesia care unit.     

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.     

Incidence and severity of postoperative nausea and vomiting are similar after metoclopramide 20 mg and ondansetron 8 mg given by the end of laparoscopic cholecystectomies

BACKGROUND: Ondansetron has a well documented antiemetic prophylactic effect, whereas in most studies of postoperative nausea and vomiting (PONV), metoclopramide is less efficacious. This can be attributed to the short-lasting effect of metoclopramide when a low dose is given at the beginning of surgery. We wanted to test a 20-mg dose of metoclopramide given at the end of surgery, using ondansetron 8 mg as a reference. METHODS: 122 patients scheduled for elective laparoscopic cholecystectomy under general anesthesia were studied in a randomized, double-blind study design. At the end of the procedure, the patients received either metoclopramide 20 mg or ondansetron 8 mg intravenously. The patients were observed for 24 h for PONV, pain, side-effects and need for rescue antiemetic medication. RESULTS: No significant differences in the incidence of PONV or need for rescue antiemetic treatment was observed in the 0-24 h postoperative study period. The overall incidence of PONV was 43% in the ondansetron group and 47% in the metoclopramide group. The ondansetron patients had a significantly higher incidence of moderate or strong pain during the postoperative observation period (61% vs. 35% in the metoclopramide group) (P < 0.05). No significant differences in side-effects between the groups were observed. CONCLUSIONS: Metoclopramide 20 mg i.v. given at the end of laparoscopic cholecystectomy resulted in a similar incidence of PONV compared with ondansetron 8 mg. The patients receiving metoclopramide had less pain than the patients receiving ondansetron.     

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.     

The Dose-Response Relationship of Ondansetron in Preventing Postoperative Emesis in Pediatric Patients Undergoing Ambulatory Surgery

Background: Postoperative nausea and vomiting is a distressing anesthetic complication that may delay discharge after ambulatory surgery. Effective prophylaxis for postoperative nausea and vomiting can be achieved in adults with lower doses of ondansetron, a 5-hydroxytryptamine subtype 3 receptor antagonist, compared with chemotherapy-induced emesis. However, the doses of ondansetron used in preventing postoperative nausea and vomiting in children are based on data from chemotherapy-induced emesis. The dose-related efficacy of intravenous ondansetron in the prophylaxis of postoperative emesis in the pediatric outpatient population was determined.

Methods: In a double-blind, randomized placebo-controlled study, 130 patients (mean age 5.7 plus/minus 3.4 yr) received placebo, 10, 50, or 100 micro gram/kg ondansetron during a standardized anesthetic. Episodes of postoperative vomiting or retching were recorded.

Results: Intravenous ondansetron in a dose of 50 micro gram/kg was more effective than placebo or a dose of 10 micro gram/kg in controlling the incidence and frequency of emesis in the hospital and during the first 24 postoperative hours. Increasing the dose of ondansetron to 100 micro gram/kg intravenously did not significantly reduce the incidence or frequency of emesis compared to 50 micro gram/kg intravenously.