scholarly journals Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials

BMJ ◽  
1995 ◽  
Vol 311 (7009) ◽  
pp. 844-846 ◽  
Author(s):  
R. L Aspinall ◽  
N. W Goodman
Keyword(s):  
Effective Treatment ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Clinical Information ◽  
Poor Quality ◽  
Nausea And Vomiting ◽  
Controlled Trials

Omission of Nitrous Oxide during Anesthesia Reduces the Incidence of Postoperative Nausea and Vomiting

1996 ◽  
Vol 85 (5) ◽  
pp. 1055-1062 ◽  
Author(s):  
Jigeeshu V. Divatia ◽  
Jayant S. Vaidya ◽  
Rajendra A. Badwe ◽  
Rohini W. Hawaldar
Keyword(s):  
Nitrous Oxide ◽  
Subgroup Analysis ◽  
Postoperative Nausea ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Trials ◽  
Maximal Effect ◽  
Randomized Controlled

Background Postoperative nausea and vomiting are important causes of morbidity after general anesthesia. Nitrous oxide has been implicated as an emetogenic agent in many studies. However, several other trials have failed to sustain this claim. The authors tried to resolve this issue through a meta-analysis of randomized controlled trials comparing the incidence of postoperative nausea and vomiting after anesthesia with or without nitrous oxide. Methods Of 37 published studies retrieved by a search of articles indexed on the MEDLINE database from 1966 to 1994, 24 studies (26 trials) with distinct nitrous-oxide and non-nitrous oxide groups were eligible for the meta-analysis. The pooled odds ratio and relative risk were calculated. Post boc subgroup analysis was also performed to qualify the result. Results The pooled odds ratio was 0.63 (0.53 to 0.75). Omission of nitrous oxide reduced the risk for postoperative nausea and vomiting by 28% (18% to 37%). In the subgroup analysis, the maximal effect of omission of nitrous oxide was seen in female patients. In patients undergoing abdominal surgery and general surgical procedures, the effect of omission of nitrous oxide, although in the same direction, was not significant. Conclusion Omission of nitrous oxide reduced the odds of postoperative nausea and vomiting by 37%, a reduction in risk of 28%.

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

2002 ◽  
Vol 97 (6) ◽  
pp. 1387-1392 ◽  
Author(s):  
Margarita Coloma ◽  
Paul F. White ◽  
Babatunde O. Ogunnaike ◽  
Scott D. Markowitz ◽  
Philip M. Brown ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Postoperative Nausea ◽  
Response Rate ◽  
Complete Response Rate ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Combination Group ◽  
Quality Of Recovery

Background This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand 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; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. 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. Conclusions Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy.

scholarly journals Comparison of Ondansetron and Dexamethasone for Prophylaxis of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgeries: A Meta-Analysis of Randomized Controlled Trials

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Souvik Maitra ◽  
Anirban Som ◽  
Dalim K. Baidya ◽  
Sulagna Bhattacharjee
Keyword(s):  
Postoperative Nausea ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Trials ◽  
Postoperative Vomiting ◽  
Pubmed Central ◽  
Randomized Controlled ◽  
Equal Efficacy

Background.Postoperative nausea and vomiting (PONV) is a significant complication after laparoscopic surgeries. Ondansetron and dexamethasone are most commonly used drugs for PONV prophylaxis. Comparisons of these two drugs have not been systematically reviewed till date.Methods.PubMed, PubMed Central, and CENTRAL databases were searched with the following words: “dexamethasone,” “ondansetron,” “laparoscopy,” and “PONV” to identify randomized trials that compared ondansetron and dexamethasone for PONV prophylaxis after laparoscopic surgeries.Results.Data of 592 patients from 7 RCTs have been included in this meta-analysis. Incidence of postoperative nausea at 4–6 h is significantly lower when dexamethasone was used instead of ondansetron (p=0.04; OR 0.49, 95% CI 0.24–0.98, M-H fixed). Incidence of nausea is similar at 24 hours (p=0.08, OR 0.71, 95% CI 0.48, 1.05; M-H fixed); vomiting is also similar at 4–6 h (p=0.43, OR 1.27, 95% CI 0.70–2.27; M-H fixed) and also at 24 h (p=0.46, OR 0.92, 95% CI 0.73, 1.16; M-H fixed).Conclusion.Dexamethasone is superior to ondansetron in preventing postoperative nausea after 4–6 h of laparoscopic surgeries. However, both the drugs are of equal efficacy in preventing postoperative vomiting up to 24 h after surgery. However, results should be interpreted with caution due to clinical heterogeneity in the included studies.

Comparative Efficacy of Acustimulation (ReliefBand®) versus Ondansetron (Zofran®) in Combination with Droperidol for Preventing Nausea and Vomiting

2002 ◽  
Vol 97 (5) ◽  
pp. 1075-1081 ◽  
Author(s):  
Paul F. White ◽  
Tijani Issioui ◽  
Jie Hu ◽  
Stephanie B. Jones ◽  
Jayne E. Coleman ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Plastic Surgery ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Normal Diet ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Combination Group ◽  
Quality Of Recovery

Background Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand to ondansetron (Zofran) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. Methods A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand. The incidences of postoperative nausea and vomiting, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. Results Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 +/- 10 vs.70 +/- 20) and patient satisfaction (94 +/- 10 vs. 75 +/- 22) scores were significantly higher in the combination group the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. Conclusions The ReliefBand compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery.

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