Intravenous Ondansetron in Established Postoperative Emesis in Children

1996 ◽  
Vol 85 (2) ◽  
pp. 270-276 ◽  
Author(s):  
Samia Khalil ◽  
Alexander Rodarte ◽  
Craig B. Weldon ◽  
Michael Weinstein ◽  
Zvi Grunwald ◽  
...  
Keyword(s):  
Nitrous Oxide ◽  
Placebo Group ◽  
Median Time ◽  
Drug Administration ◽  
Rescue Medication ◽  
Hospital Admissions ◽  
Outpatient Surgery ◽  
Study Drug ◽  
Double Blind ◽  
Study Drug Administration

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 < or = 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. Conclusion A single dose of ondansetron (0.1 mg/kg up to 4 mg) is effective and well tolerated in the prevention of further episodes of postoperative emesis in children after outpatient surgery. Administration of ondansetron also may result in a shorter time to discharge.

Effectiveness of Terbutaline and Theophylline Alone and in Combination in Exercise-Induced Bronchospasm

PEDIATRICS ◽  
1981 ◽  
Vol 67 (4) ◽  
pp. 508-513
Author(s):  
Gail G. Shapiro ◽  
Joseph J. McPhillips ◽  
Kevin Smith ◽  
Clifton T. Furukawa ◽  
William E. Pierson ◽  
...  
Keyword(s):  
Drug Administration ◽  
Study Drug ◽  
Forced Expiratory Volume ◽  
Exercise Tests ◽  
Double Blind ◽  
Study Drug Administration ◽  
Before And After ◽  
Forced Expiratory Flow ◽  
Exercise Induced ◽  
Better Than

Theophylline and terbutaline, alone and in combination, were evaluated for effectiveness in treating exercise-induced bronchospasm (EIB) when used at doses that should be tolerated by adolescents taking them intermittently: theophylline, 250 mg (fast release), and terbutaline, 2.5 mg. Twenty-one subjects, 12 to 19 years of age, with EIB performed standardized exercise tests on four separate days and received either theophylline, terbutaline, the combination, or placebo in a prerandomized double-blind manner prior to exercise. Exercise tests were performed two and five hours after each study drug administration. Blood samples were drawn before and again two and five hours after drug administration for theophylline level. Pulmonary function [forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and forced expiratory flow rate (FEF25% to 75%)] was recorded before and after exercise. All of the active treatments were better than placebo in diminishing EIB. The combination was statistically better than terbutaline or theophylline alone. The effect of theophylline was not significantly different from that of terbutaline. The combination induced significantly more tremor than either agent individually. Either drug alone or the two in combination is effective for diminishing EIB. Although the combination may have additive properties for some patients, the increased incidence of tremor may diminish its appeal. Either drug alone or in combination is effective in decreasing EIB for at least five hours, which makes them practical choices for treatment of school-aged children.

Abstract 11817: The Effect of Time to Treatment With Antiarrhythmic Drugs on Return of Spontaneous Circulation in Shock Refractory Out-of-Hospital Cardiac Arrest: A Secondary Analysis of the ALPS Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Mahbod Rahimi ◽  
Paul Dorian ◽  
Sheldon Cheskes ◽  
Gerald Lebovic ◽  
Steve Lin
Keyword(s):  
Cardiac Arrest ◽  
Drug Administration ◽  
Controlled Trial ◽  
Group Versus ◽  
Study Drug ◽  
Spontaneous Circulation ◽  
Study Drug Administration ◽  
Time To Treatment ◽  
Return Of Spontaneous Circulation ◽  
Hospital Cardiac Arrest

Purpose: The effects of amiodarone and lidocaine on the return of spontaneous circulation (ROSC), relative to time to treatment in out of hospital cardiac arrest (OHCA) patients is unknown. We conducted a post-hoc analysis of the Resuscitation Outcomes Consortium Amiodarone, Lidocaine, Placebo (ROC ALPS) randomized trial examining the association of time to treatment with ROSC at emergency department (ED) arrival. Method: In the ROC ALPS trial, adults with non-traumatic OHCA with initial VF/pVT after ≥ 1 shock were randomized to receive amiodarone, lidocaine or placebo. We used logistic regression to examine the association of time to treatment (911 call to study drug administration interval) with ROSC at ED arrival. Results: Overall, 1112 (36.7%) patients had ROSC at ED arrival. Time to treatment data were available for 2994 (99%) of the patients. The proportion of patients with ROSC at ED arrival decreased as time to drug administration increased, in amiodarone (OR 0.92, 95% CI 0.90-0.94 per min increase), lidocaine (OR 0.95, 95% CI: 0.93-0.96) and placebo (OR 0.95, 95% CI: 0.93-0.96) arms. The odds of ROSC at ED in the amiodarone group (versus placebo) changed in relation to the time of drug administration (OR 0.96, 95% CI: 0.93-0.99). With short times to drug administration, ROSC was higher in amiodarone versus placebo recipients, whereas ROSC was higher with placebo at later times. Comparing lidocaine to placebo, ROSC rate increased at all times (OR 1.29, 95% CI: 1.07-1.59); there was no time to drug administration effect (OR 1.00, 95% CI: 0.97-1.03). Among all patients, survival at hospital discharge was 21.0%, 24.4%, and 23.7% for placebo, amiodarone and lidocaine respectively. Conclusion: Amiodarone’s efficacy in restoring ROSC declined with longer duration of arrest, potentially due to its adverse hemodynamic effects. Overall, amiodarone and lidocaine had similar effects on mortality; in this study, ROSC at ED arrival trend did not reflect the overall survival rate

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Economic evaluation of DVd versus VAd in the treatment of multiple myeloma: Results from a phase III multicenter randomized clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6050-6050
Author(s):  
R. M. Rifkin ◽  
M. Hussein ◽  
R. Iskandar ◽  
A. O’Sullivan ◽  
D. Thompson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Economic Evaluation ◽  
Drug Administration ◽  
Study Drug ◽  
Phase Iii ◽  
Study Drug Administration ◽  
Reduced Dose ◽  
Hospitalization Costs

6050 Background: A randomized Phase III clinical trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone (DVd) versus conventional doxorubicin, vincristine, and reduced-dose dexamethasone (VAd) found similar efficacy in the treatment of newly-diagnosed multiple myeloma (Cancer, in press). However, observed clinical advantages of DVd included less toxicity and supportive care. (Cancer In press). Methods: This economic evaluation was conducted as a piggyback to the clinical trial. Utilization data were collected prospectively for enrolled patients (DVd = 97; VAd = 95). Costs were estimated by applying standard US unit costs in 2004 to observed utilization. We compared resource utilization and costs for study drug administration, other care (hospitalizations due to AEs, tests, transfusions, and concomitant medications), and total costs during follow-up for patients receiving DVd versus VAd using 2-sided t-tests. Results: DVd patients required significantly fewer hospital (1.5 vs 8.5; p < 0.01) and clinic days (4.8 vs 14.4; p < 0.01) for study drug administration. Costs of study drug were significantly higher for DVd patients ($16,181 vs $788; p < 0.01), but lower hospitalization costs ($3,311 vs $18,492; p < 0.01) and clinic costs ($797 vs $2,412; p < 0.01) for drug administration more than offset these costs, resulting in nominally lower overall study drug administration costs for DVd versus VAd ($20,289 vs $21,692; p = 0.64). No other component of care differed significantly between the two groups (costs of other care: $14,152 for DVd vs $14,154 for VAd; p = 0.99) and overall treatment costs ($34,442 for DVd vs $35,846 for VAd; p = 0.76) were similar in the two groups. DVd patients had approximately 10 additional days of follow-up over the trial period (149.4 vs 139.2) versus VAd patients. Conclusions: Despite higher drug acquisition costs, use of DVd did not increase the overall cost of treatment compared to VAd. [Table: see text]

scholarly journals Contribution of parasympathetic muscarinic augmentation of insulin secretion to olanzapine-induced hyperinsulinemia

2018 ◽  
Vol 315 (2) ◽  
pp. E250-E257 ◽  
Author(s):  
Michael R. Rickels ◽  
Elys M. Perez ◽  
Amy J. Peleckis ◽  
Erica Alshehabi ◽  
Huong-Lan Nguyen ◽  
...  
Keyword(s):  
Insulin Secretion ◽  
Glucose Tolerance ◽  
Insulin Response ◽  
Study Drug ◽  
Psychiatric Disease ◽  
Double Blind ◽  
Study Drug Administration ◽  
Intravenous Glucose ◽  
Obesity And Diabetes ◽  
Hepatic Insulin Extraction

Atypical antipsychotic drugs have been associated with the development of obesity and diabetes. In particular, olanzapine can induce peripheral insulin resistance and compensatory hyperinsulinemia independent of weight gain or psychiatric disease. To determine if this compensatory increase in insulin is mediated by parasympathetic muscarinic stimulation, we randomized 15 healthy subjects 2:1 to receive double-blind olanzapine or placebo for 9 days under diet- and activity-controlled inpatient conditions. Before and after 7 days of study drug administration, subjects underwent frequently sampled intravenous glucose tolerance tests with either saline or atropine infused on subsequent days to assess insulin secretion and hepatic insulin extraction in the absence or presence of muscarinic blockade. We found that olanzapine led to an increase in the acute insulin response to glucose, which was not seen with placebo, and was attenuated in the olanzapine group by atropine. Deconvolution of C-peptide data confirmed an increase in insulin secretion with olanzapine, which was blocked by atropine, with a modest reduction in hepatic insulin extraction with olanzapine. These results support the contribution of muscarinic augmentation of insulin secretion to olanzapine-induced hyperinsulinemia, and provide a mechanism for the compensatory hyperinsulinemia that normally serves to prevent deterioration of glucose tolerance under conditions of metabolic challenge.

scholarly journals Preoperative Transdermal Hyoscine for the Prevention of Postoperative Nausea and Vomiting

1989 ◽  
Vol 17 (3) ◽  
pp. 285-289 ◽  
Author(s):  
A. R. Wilkinson ◽  
C. M. A Frampton ◽  
P. W. Glover ◽  
F. M. Davis
Keyword(s):  
Nitrous Oxide ◽  
Placebo Group ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind Study ◽  
Transdermal Patch ◽  
Double Blind ◽  
Group 12 ◽  
Minor Surgery

In a randomised, double-blind study, a transdermal patch containing either hyoscine or placebo was applied post-auricularly in 190 adult patients under 65 years old, seven to twelve hours prior to their undergoing minor orthopaedic or plastic surgery under thiopentone/nitrous oxide/halothane general anaesthesia. In the first 24 hours after surgery 34% of patients vomited. The incidence of nausea (31% vs 54%; P< 0.01) and the number of episodes of vomiting (66 vs 125; P< 0.05) during the first 24 hours were significantly less with hyoscine than with placebo. The hyoscine group required fewer doses of antiemetic than the placebo group (12 vs 27; P < 0.05). Side-effects were mild, the only difference between the two groups being the frequency of dry mouth immediately preoperatively. No differences were seen in the second 24 hours after surgery. We conclude that transdermal hyoscine is moderately effective in reducing the occurrence of postoperative nausea and vomiting following minor surgery.

Enoxaparin for the Prevention of Venous Thromboembolism Associated With Central Vein Catheter: A Double-Blind, Placebo-Controlled, Randomized Study in Cancer Patients

2005 ◽  
Vol 23 (18) ◽  
pp. 4057-4062 ◽  
Author(s):  
Melina Verso ◽  
Giancarlo Agnelli ◽  
Sergio Bertoglio ◽  
Franco C. Di Somma ◽  
Francesco Paoletti ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Randomized Study ◽  
Study Drug ◽  
Placebo Treatment ◽  
Bleeding Complications ◽  
Central Vein ◽  
Double Blind Study ◽  
Double Blind ◽  
Study Drug Administration

Purpose The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE. Patients and Methods In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications. Results Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period. Conclusion In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.

scholarly journals Prevention of acute respiratory viral infections and influenza in children during the peaks of seasonal morbidity: the results of the international double-blind placebo-controlled randomized clinical trial

2020 ◽  
Vol 65 (3) ◽  
pp. 109-120
Author(s):  
N. A. Geppe ◽  
A. V. Gorelov ◽  
O. V. Shamsheva ◽  
I. G. Sitnikov ◽  
E. P. Sitnikova ◽  
...  
Keyword(s):  
Placebo Group ◽  
Bacterial Infections ◽  
Viral Infections ◽  
Group Versus ◽  
Study Drug ◽  
Preventive Therapy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Respiratory Viral Infections

The authors conducted an international multicenter double-blind, placebo-controlled clinical study to obtain additional data on the efficacy and safety of a 12-week course of Anaferon for children for the prevention of acute respiratory viral infections (ARVI), including influenza, in children during the rise in seasonal morbidity (RCT of the Ministry of Health of the Russian Federation: №356 dated June 29, 2017; ClinicalTrials.gov Identifier: NCT03301155).Materials and methods. The study involved 1,036 children (1 month – 6 years 11 months 29 days) during two epidemiological seasons. The patients were divided into 2 groups: 528 patients received Anaferon for children 1 tablet a day for 12 weeks, 508 patients received placebo according to Anaferon for children scheme. The primary end point was the duration of the period from the first dose of the drug until manifestation of ARVI/influenza. Additional end points were percentage of children not falling with ARVI/influenza during 4-, 8- and 12-week course of preventive therapy; percentage of children with respiratory or ear-nose-throat bacterial infections requiring antibiotics within 12 week; percentage of children hospitalized with ARVI/influenza or their complications within 12 week. To assess safety, the authors analyzed the presence and nature of the adverse events (AEs), their severity, connection with the medication, outcome. The authors used the following statistical methods: calculation of hazard ratio, median time to the manifestation of symptoms of ARVI / influenza, 95% confidence intervals.Results. The Intention-to-treat (ITT) and Per Protocol [РР] analysis included the data of 1,021 [975] patients: 520 [494] – Anaferon for children group and 501 [481] –Placebo group. The average duration of the period from the first dose of the drug to the development of ARVI/influenza symptoms obtained as a result of the analysis of the statistical model was 428.8 [434.1] days for Anaferon for children group, that is 1.5 times higher than in Placebo group (275.8 [274.9] days; p=0.001 [p=0.0009]). The percentage of children without ARVI/influenza was 99.2% [99.2%] in Anaferon for children group (versus 90.2% [90.0%] in Placebo group; p=0.0003 [p=0.0003]) within 4 weeks, 92.7% [92.3%] (versus 82.8% [82.7%]; p=0.0003 [p=0.0003]) within 8 weeks, and 81.5% [81.8%] (versus 73.4% [73.4%], respectively; p=0.0021 [p=0.0021]). None of the patients was hospitalized for ARVI/influenza or complications. The frequency of AEs in Anaferon for children and Placebo groups had no differ. No one AE definitely related to the study drug was registered.Conclusion. The results confirm the efficacy and safety of a 12-week course of Anaferon for children to prevent ARVI and influenza during seasonal rise of morbidity in children.

Naproxen Sodium in the Treatment of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
ES Johnson ◽  
DM Ratcliffe ◽  
M Wilkinson
Keyword(s):  
Placebo Group ◽  
Rescue Medication ◽  
Naproxen Sodium ◽  
Double Blind ◽  
Treatment Groups ◽  
Parallel Group ◽  
Significant Difference ◽  
Previous Visit ◽  
Premonitory Symptoms ◽  
Visual Disturbances

Seventy patients with classical or common migraine were treated during their attacks with either naproxen sodium or placebo in a randomised, double-blind parallel group study. The initial dose of naproxen sodium was 825 mg followed one hour later by a further 550 mg, if symptoms were the same or had improved. If the migraine symptoms had worsened, patients were offered an escape analgesic combination of 1000 mg paracetamol and 10 mg metoclopramide. Patients were assessed at monthly intervals for changes in the severity and duration of headache, premonitory symptoms (mainly visual disturbances) and photophobia, nausea and vomiting associated with migraine attacks that had occurred since the previous visit. Patients were studied for a maximum of ten attacks and significant improvement was observed in the severity and duration of headache when the patients were on naproxen sodium. Also the premonitory symptoms and photophobia improved significantly on naproxen sodium and significantly less rescue analgesics were required. Patients suffering from common migraine had less severe headaches and photophobia when taking naproxen sodium than when taking placebo and the headaches were shorter in duration and patients took less rescue analgesic. No significant difference was observed between the treatment groups in patients with classical migraine. Ten patients in the placebo group and six in the naproxen sodium group reported side-effects but these were possibly related to the use of rescue medication. Naproxen sodium proved safe and effective in common migraine attacks, but in this study efficacy was not established for classical migraine.

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