Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting and Impact on Functional Quality of Living During Recovery in Patients with High Emetic Risks: A Prospective, Randomized, Double-Blind Comparison of Two Prophylactic Antiemetic Regimens

2008 ◽  
Vol 107 (2) ◽  
pp. 429-438 ◽  
Author(s):  
Peter H. Pan ◽  
Sherman C. Lee ◽  
Lynne C. Harris
Keyword(s):  
Nausea And Vomiting ◽  
Double Blind ◽  
Antiemetic Prophylaxis ◽  
Functional Quality ◽  
Quality Of Living ◽  
Blind Comparison

scholarly journals Epidural Pethidine or Fentanyl during Caesarean Section: A Double-Blind Comparison

1989 ◽  
Vol 17 (2) ◽  
pp. 157-165 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Single Bolus Dose ◽  
Clinical Advantage ◽  
Blind Comparison

The onset, quality and duration of analgesia and side-effects of a single bolus dose of either epidural pethidine 50 mg or fentanyl 100 mcg, administered immediately post-delivery, were compared in a randomised, double-blind study of fifty-five women undergoing epidural caesarean section. The onset of effect was more rapid with fentanyl, a significantly larger number of women achieving complete pain relief fifteen minutes post-administration (P<0.05). The quality of analgesia was good in both groups and the quality and duration of effective analgesia not significantly different. The incidence and severity of side-effects were low, with no significant difference between groups. One patient in the pethidine group experienced early onset respiratory depression; however, she did not require active treatment. Epidural fentanyl 100 mcg appears to offer a small clinical advantage over pethidine 50 mg for intraoperative use during caesarean section.

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)

2017 ◽  
Vol 35 (31) ◽  
pp. 3558-3565 ◽  
Author(s):  
Lingyun Zhang ◽  
Xiujuan Qu ◽  
Yuee Teng ◽  
Jing Shi ◽  
Ping Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Delayed Nausea

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

scholarly journals Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery

2020 ◽  
Vol 132 (6) ◽  
pp. 1419-1428 ◽  
Author(s):  
Jaime B. Hyman ◽  
Chang Park ◽  
Hung-Mo Lin ◽  
Beatriz Cole ◽  
Leigh Rosen ◽  
...  
Keyword(s):  
Placebo Group ◽  
Relative Risk ◽  
Ambulatory Surgery ◽  
Controlled Trial ◽  
Interquartile Range ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Severe Nausea ◽  
Double Blind ◽  
Antiemetic Prophylaxis

Abstract Background Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting. Methods In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects. Results A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023). Conclusions When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 h after discharge from ambulatory surgery by about 60% with a slight increase in reported sedation. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Randomized, double-blind comparison of ondansetron versus ondansetron plus metopimazine as antiemetic prophylaxis during platinum-based chemotherapy in patients with cancer.

1997 ◽  
Vol 15 (4) ◽  
pp. 1690-1696 ◽  
Author(s):  
J Herrstedt ◽  
T Sigsgaard ◽  
J Handberg ◽  
B M Schousboe ◽  
M Hansen ◽  
...  
Keyword(s):  
Complete Response ◽  
Treatment Preference ◽  
Double Blind ◽  
Antiemetic Effect ◽  
Patients With Cancer ◽  
Antiemetic Prophylaxis ◽  
Platinum Based Chemotherapy ◽  
Dopamine D2 Antagonist ◽  
Efficacy Parameters ◽  
Blind Comparison

PURPOSE To investigate the antiemetic effect and tolerability of the 5-hydroxytryptamine3(5-HT3) antagonist ondansetron plus the dopamine D2 antagonist metopimazine versus ondansetron alone in patients receiving platinum-based chemotherapy. PATIENTS AND METHODS One hundred eleven chemotherapy-naive patients who were scheduled to receive two consecutive courses of platinum-based chemotherapy were randomized between ondansetron 8 mg intravenously (IV) followed by 8 mg orally twice a day plus metopimazine 35 mg/m2 as a 24-hour continuous infusion followed by 30 mg orally four times a day for 4 days, or ondansetron plus placebo. The study used a double-blind, crossover, placebo-controlled design. RESULTS Ninety-four patients completed the crossover. Complete response (CR; no emetic episodes) was obtained on day 1 in 77.7% of the patients who received the combination versus 50.0% of those who received ondansetron alone (P = .00002), and in 51.7% versus 31.0% on days 2 to 6 (P = .0009). The overall CR (days 1 to 6) was 48.9% versus 25.3% (P = .0002). Additionally, significantly less nausea was observed with the combination on day 1 (P = .0002), days 2 to 6 (P = .0001), and days 1 to 6 (P = .00004). Patient preference was 63.6% for the combination and 13.6% for ondansetron alone; 22.7% expressed no treatment preference (P < .0001; therapeutic gain 50.0%; 95% confidence interval [CI], 31.6% to 68.4%). Adverse reactions were mild and without significant differences between the two treatments. CONCLUSION Metopimazine plus ondansetron was significantly superior to ondansetron alone, concerning all efficacy parameters assessed, in patients who received platinum-based chemotherapy.

Assessing duration of breakthrough chemotherapy-induced nausea and vomiting (CINV): A pooled study analysis of NEPA versus aprepitant.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12091-12091
Author(s):  
Rudolph M. Navari ◽  
Gary Binder ◽  
Erminio Bonizzoni ◽  
Rebecca Clark-Snow ◽  
Silvia Olivari Tilola ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Strong Predictor ◽  
Complete Response ◽  
Pooled Analysis ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Phase Duration ◽  
Antiemetic Prophylaxis ◽  
Significant Nausea

12091 Background: The historical standard clinical trial endpoint for preventing chemotherapy-induced nausea and vomiting (CINV) has been assessment of complete response (CR: no emesis and no rescue medication use) over five days. Recent evaluations focused on the duration of breakthrough CINV suggest that long duration of CINV results in more lost work time and impaired activity and is also a strong predictor for CINV in subsequent cycles. A recent pooled analysis of three similarly designed registration trials of NEPA, a fixed oral combination NK1 receptor antagonist (RA) (netupitant)/5-HT3RA (palonosetron), showed significantly higher CR rates during the delayed phase (≥24-120h) for NEPA compared to an aprepitant (APR) regimen. In this post-hoc analysis, we evaluated the extent and duration of breakthrough CINV in these pooled studies. Methods: Chemotherapy-naïve patients who received cisplatin-based chemotherapy and antiemetic prophylaxis of either a single dose of NEPA plus dexamethasone (DEX) or a 3-day APR/5-HT3 RA/DEX regimen from three randomized, double-blind pivotal trials were included. Patients without a CR were defined as treatment failures. Extent of CINV was evaluated using proportions of patients with treatment failure, emesis, and significant nausea (defined as >25 mm on a 100 mm visual analog scale). Over the 5-day overall phase, duration was categorized as 1-2, and ≥3 days. Pearson’s chi-square test was employed to compare risks between treatments for each duration category in each of the previously mentioned endpoints. Results: Among all 621 NEPA and 576 APR patients, a significantly greater proportion of APR patients experienced treatment failure, emesis, and significant nausea for ≥3 days. Specifically, among patients with treatment failure, 31% (41/134) who received NEPA and 43% (61/143) who received APR experienced breakthrough CINV for ≥3 days. Conclusions: Expanding on data suggesting single-day NEPA is more effective than 3-day APR in preventing delayed CINV, NEPA is also more effective in minimizing the extent and duration of CINV in patients with breakthrough emesis and nausea.[Table: see text]

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