scholarly journals Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study

2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Keith A Candiotti ◽  
Syed Raza Ahmed ◽  
David Cox ◽  
Tong J Gan
CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S111-S111
Author(s):  
S. Campbell ◽  
E. Simard ◽  
A. Arcand ◽  
L. Blagrove ◽  
P. Piraino ◽  
...  

Introduction: Inhaled low dose methoxyflurane (MEOF) was recently approved in Canada for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in conscious adult patients. ADVANCE-ED is an ongoing phase IV, prospective open label study undertaken to generate real-world evidence to complement the global clinical development program through evaluation of the effectiveness of low dose MEOF in Canadian emergency departments (EDs). Methods: This multi-centre study is enrolling adult (≥18 yrs) patients with moderate to severe acute pain (NRS0-10 ≥ 4) associated with minor trauma. To address limitations from the pivotal study, this study allows patients who were excluded in the pivotal trials: namely, those with severe (≥7) pain, and those using OTC or stably dosed analgesics for other conditions, including chronic pain. Eligible patients receive a single treatment of up to 2 x 3 mL MEOF (2nd 3 mL to be provided only upon request), self-administered by the patient under medical supervision. Rescue medication is permitted at any time, if required. Results: Here we describe the patient demographics and treatment satisfaction (Global Medication Performance, GMP) at 50% enrolment (n = 49). Mean (SD) patient age is 48.0 (17.1) yrs and 55.1% are female. Mean pain (SD) reported at enrolment is 8.3 (1.5), with 73.4% of patients with NRS0-10 ≥ 8. Injuries are overwhelmingly limb trauma (87.8%). The most common type is sprain/strain (40.8%), followed by fracture (32.7%). At 5 minutes post-start of administration (STA) of MEOF, 80.4% of patients reported pain relief; this increased to 91.3% at 15 minutes, and 100% of patients reported pain relief by 30 minutes post-STA. GMP was assessed as “good”, “very good” or “excellent” by ≥80% of patients both 20 minutes post-start of administration (STA) of MEOF (83.3%) and at discharge (85.8%). When asked to what extent their expectation of pain relief had been met, 32.7% responded good, 26.5% responded “very good” and 22.4% responded “excellent”. Three quarters of enrolled patients (75.5%) did not require rescue medication. The most common (≥5%) treatment-related adverse events were dizziness (n = 14, 28.6%) and euphoric mood (n = 4, 8.2%). No serious adverse events have been reported. Conclusion: Based on 50% of the patients enrolled in this prospective, open label study, responses to inhaled low-dose MEOF are within expectation for both effectiveness and tolerability.


Author(s):  
Devendra Mishra ◽  
Girish H Patel ◽  
Rupali Gathani

<p>ABSTRACT<br />Objective: An open label study to assess the effect of colicarmin plus syrup on colic and griping pain, indigestion, nausea and vomiting in children,<br />and geriatric patients.<br />Methods: (a) A study was conducted on 75 number of patients to evaluate the effect of colicarmin plus syrup on colic and griping pain, indigestion,<br />nausea and vomiting in children, and adults, (b) mostly these children were selected from different classes of families, (c) all the patients were checked<br />on the 1<br />st<br />, 2<br />nd<br />, and 3<br />rd<br /> week after starting the therapeutic dose.<br />Dosage schedule: (a) Children: 1 Teaspoonful thrice a day after meals, (b) adults: 2 Teaspoonful twice to thrice a day after meals.<br />Results: (a) Colic and griping pain: In the total duration of treatment, no of patients recovering were 23-on 1<br />st<br /> week, 4-on 2<br /> week,<br />overall result is 93.54%, (b) indigestion: In the total duration of treatment, no of patients recovering were 26-on 1<br />st<br />nd<br /> week, and 3-on 3<br /> week, 3-on 2<br /> week, and 1-on<br />3<br />rd<br /> week, the overall result is 93.75%, (c) nausea and vomiting: In the total duration of treatment, no of patients recovering were 8-on 1<br /> week, 2-on<br />2<br />nd<br /> week, and 1-on 3<br />rd<br /> week, the overall result is 91.33%.<br />Conclusion: Based on the study, we can conclude that colicarmin plus syrup is an Ayurvedic formulation with benefits such as digestive, carminative,<br />anthelmintic, antiflatulent, antispasmodic, and devoid of side effects.<br />Keywords: Digestive, Carminative, Anthelmintic, Antiflatulent and Antispasmodic.<br />nd</p><p>st</p><p>rd</p>


1998 ◽  
Vol 89 (4) ◽  
pp. 838-843 ◽  
Author(s):  
Dajun Song ◽  
Charles W. Whitten ◽  
Paul F. White ◽  
Song Y. Yu ◽  
Eduardo Zarate

Background Controversy exists regarding the effectiveness of propofol to prevent postoperative nausea and vomiting. This prospective, randomized, single-blinded study was designed to evaluate the antiemetic effectiveness of 0.5 mg/kg propofol when administered intravenously after sevoflurane- compared with desflurane-based anesthesia. Methods Two hundred fifty female outpatients undergoing laparoscopic cholecystectomy were assigned randomly to one of four treatment groups. All patients were induced with intravenous doses of 2 mg midazolam, 2 microg/kg fentanyl, and 2 mg/kg propofol and maintained with either 1-4% sevoflurane (groups 1 and 2) or 2-8% desflurane (groups 3 and 4) in combination with 65% nitrous oxide in oxygen. At skin closure, patients in groups 1 and 3 were administered 5 ml intravenous saline, and patients in groups 2 and 4 were administered 0.5 mg/kg propofol intravenously. Recovery times were recorded from discontinuation of anesthesia to awakening, orientation, and readiness to be released home. Postoperative nausea and vomiting and requests for antiemetic rescue medication were evaluated during the first 24 h after surgery. Results Propofol, in an intravenous dose of 0.5 mg/kg, administered at the end of a sevoflurane-nitrous oxide or desflurane-nitrous oxide anesthetic prolonged the times to awakening and orientation by 40-80% and 25-30%, respectively. In group 2 (compared with groups 1, 3, and 4), the incidences of emesis (22% compared with 47%, 53%, and 47%) and requests for antiemetic rescue medication (19% compared with 42%, 50%, and 47%) within the first 6 h after surgery were significantly lower, and the time to home-readiness was significantly shorter in duration (216 +/- 50 min vs. 249 +/- 49 min, 260 +/- 88 min, and 254 +/- 72 min, respectively). Conclusions A subhypnotic intravenous dose of propofol (0.5 mg/kg) administered at the end of outpatient laparoscopic cholecystectomy procedures was more effective in preventing postoperative nausea and vomiting after a sevoflurane-based (compared with a desflurane-based) anesthetic.


1994 ◽  
Vol 28 (2) ◽  
pp. 179-181 ◽  
Author(s):  
Ghassem E. Larijani ◽  
Irwin Gratz ◽  
Mary Afshar

OBJECTIVE: To evaluate the presence and the relationship between postoperative nystagmus and nausea. DESIGN: Open-label study. SETTING: University hospital. PATIENTS: Sixty-six patients recovering from general anesthesia following elective ambulatory surgeries. INTERVENTIONS: Patients were tested postoperatively for nystagmus using an electronystagmography, and were monitored for nausea and vomiting for the first postoperative day. MAIN OUTCOME MEASURES: A comparison of the incidence of nausea was made among patients with and without postoperative nystagmus. RESULTS: Twenty-four patients (36 percent) experienced postoperative nausea and 28 patients (42 percent) had nystagmus. There were no significant differences in age, weight, height, dosage of fentanyl, or postoperative use of narcotics between those who experienced postoperative nausea or had nystagmus than those who did not. A significantly greater percentage of female patients compared with male patients had nausea during the first postoperative day. Sixty percent of patients with nystagmus experienced nausea in the hospital compared with 18 percent of the patients without nystagmus (p<0.01, 95 percent confidence interval [CI] of the difference = 11.3 to 61.3 percent). Twenty-two patients (78 percent) with nystagmus experienced nausea during the first postoperative day compared with 14 patients (36 percent) with no nystagmus (p<0.01, 95 percent CI of the difference = 20.1 to 63.3 percent). Eighty-three percent of the nauseated patients experienced vomiting during the first postoperative day. CONCLUSIONS: The presence of nystagmus in the early part of recovery from general anesthesia is associated with a higher incidence of nausea and vomiting during the first postoperative day.


2018 ◽  
Vol 128 (6) ◽  
pp. 1099-1106 ◽  
Author(s):  
Peter Kranke ◽  
Sergio D. Bergese ◽  
Harold S. Minkowitz ◽  
Timothy I. Melson ◽  
David G. Leiman ◽  
...  

Abstract Background Postoperative nausea and vomiting causes distress for patients and can prolong care requirements. Consensus guidelines recommend use of multiple antiemetics from different mechanistic classes as prophylaxis in patients at high risk of postoperative nausea and vomiting. The prophylactic efficacy of the dopamine D2/D3 antagonist amisulpride in combination with other antiemetics was investigated. Methods This double-blind, randomized, placebo-controlled, international, multicenter trial was conducted in 1,147 adult surgical patients having three or four postoperative nausea and vomiting risk factors. Patients were randomized to receive either intravenous amisulpride (5 mg) or matching placebo at induction of general anesthesia, in addition to one standard, nondopaminergic antiemetic, most commonly ondansetron or dexamethasone. Vomiting/retching, nausea, and use of rescue medication were recorded for 24 h after wound closure. The primary endpoint was complete response, defined as no emesis or rescue medication use in the 24-h postoperative period. Results Complete response occurred in 330 of 572 (57.7%) of the amisulpride group and 268 of 575 (46.6%) of the control group (difference 11.1 percentage points; 95% CI, 5.3 to 16.8; P &lt; 0.001). The incidences of emesis (13.8% vs. 20.0%, P = 0.003), any nausea (50.0% vs. 58.3%, P = 0.002), significant nausea (37.1% vs. 47.7%, P &lt; 0.001), and rescue medication use (40.9% vs. 49.4%, P = 0.002) were significantly lower in the amisulpride group. Adverse events and laboratory and electrocardiogram abnormalities occurred no more frequently with amisulpride than with placebo. Conclusions Intravenous amisulpride was safe and effective as prophylaxis of postoperative nausea and vomiting when given in combination with an antiemetic from another class to adult patients at high risk for suffering postoperative nausea and vomiting undergoing elective surgery under inhalational general anesthesia.


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