A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy.

1990 ◽  
Vol 8 (6) ◽  
pp. 1063-1069 ◽  
Author(s):  
J Bonneterre ◽  
B Chevallier ◽  
R Metz ◽  
P Fargeot ◽  
E Pujade-Lauraine ◽  
...  
Keyword(s):  
Group Analysis ◽  
Loading Dose ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Parallel Group ◽  
Blind Comparison ◽  
Prophylaxis Of Emesis ◽  
To Receive ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Seventy-five breast cancer patients scheduled to receive a first course (in a new cycle) of cyclophosphamide, fluorouracil, and doxorubicin (FAC) or epirubicin (FEC) participated in a double-blind crossover study to compare the antiemetic efficacy and safety of ondansetron (GR38032), a 5-hydroxytryptamine3 (5-HT3) receptor antagonist, and metoclopramide. Ondansetron was given as an 8 mg loading dose (4 mg intravenously [IV] plus 4 mg orally) before chemotherapy followed by 8 mg every 8 hours orally for 3 to 5 days. Metoclopramide was given as an 80 mg loading dose (60 mg IV plus 20 mg orally) before chemotherapy followed by 20 mg every 8 hours orally for 3 to 5 days. A "period" interaction in the analysis of emetic response in the first 24 hours necessitated a parallel group analysis of first treatments only, 68 patients being assessable for this parameter. In the first 24 hours, complete or major control (zero to two emetic episodes) of emesis was achieved in 30 of 35 (86%) patients receiving ondansetron and in 14 of 33 (42%) patients receiving metoclopramide (P less than .001). Ondansetron was also more effective in reducing acute nausea. On days 2 to 3, the complete or major responses were significantly better with ondansetron (81% v 65%; P = .033), but there was no statistical difference in the control of nausea. There was a significant patient preference for ondansetron (63% v 26%; P = .001). Extrapyramidal reactions were observed in two metoclopramide treatments; both treatments were otherwise well tolerated. These results are consistent with serotonin (5-HT), being a significant neurotransmitter of cyclophosphamide/doxorubicin- or epirubicin/fluorouracil-induced emesis.

Co-Phenylcaine Spray: can we improve the taste? A randomised, double-blind, crossover study

2017 ◽  
Vol 132 (2) ◽  
pp. 138-142
Author(s):  
S Bailey ◽  
B Panizza ◽  
P Cabot ◽  
B Wallwork
Keyword(s):  
Crossover Study ◽  
Nasal Spray ◽  
Patient Experience ◽  
Washout Period ◽  
Sensory Attributes ◽  
Satisfaction Score ◽  
Double Blind ◽  
To Receive ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

AbstractObjective:Co-Phenylcaine Forte is a nasal spray routinely prescribed by otolaryngologists in Australia. The taste of Co-Phenylcaine Forte is typically described as unpleasant. This study sought to improve the overall patient experience associated with Co-Phenylcaine Forte by generating a Co-Phenylcaine Forte formulation, referred to as Co-Phenylcaine Zest, which contains an added vanilla flavour and masking agent.Methods:Participants were randomised to receive two actuations of Co-Phenylcaine Forte in each nostril followed by two actuations of Co-Phenylcaine Zest, or vice versa. There was a 6–36-hour washout period between each treatment. After the administration of each spray, participants completed a questionnaire to rate various sensory attributes of each formulation on seven-point ordinal scales. Patients reported their overall formulation preference after receiving both treatments.Results:A total of 86 participants completed the trial. Seventy-four per cent of patients preferred Co-Phenylcaine Zest, 21 per cent preferred Co-Phenylcaine Forte and 5 per cent had no preference (p < 0.001). The satisfaction score associated with Co-Phenylcaine Zest was 1.22 points greater than with Co-Phenylcaine Forte (p < 0.001).Conclusion:A novel formulation of Co-Phenylcaine Forte was created by adding a flavour and a masking agent; this formulation was preferred by most patients.

scholarly journals A Prospective, Randomized, Double-Blind Comparison of 2% Mepivacaine With 1 : 20,000 Levonordefrin Versus 2% Lidocaine With 1 : 100,000 Epinephrine for Maxillary Infiltrations

2010 ◽  
Vol 57 (4) ◽  
pp. 139-144 ◽  
Author(s):  
Ingrid Lawaty ◽  
Melissa Drum ◽  
Al Reader ◽  
John Nusstein
Keyword(s):  
Crossover Study ◽  
Anesthetic Agent ◽  
Central Incisor ◽  
Double Blind ◽  
Maxillary Central Incisor ◽  
Blind Comparison ◽  
Blind Manner ◽  
Pulpal Anesthesia ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Abstract The purpose of this prospective, randomized, double-blind crossover study was to compare the anesthetic efficacy of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine in maxillary central incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary central incisor and first molar infiltrations of 1.8 mL of 2% mepivacaine with 1 : 20,000 levonordefrin and 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine at 2 separate appointments spaced at least 1 week apart. The teeth were electric pulp tested in 2-minute cycles for a total of 60 minutes. Anesthetic success (obtaining 2 consecutive 80 readings with the electric pulp tester within 10 minutes) was not significantly different between 2% mepivacaine with 1 : 20,000 levonordefrin and 2% lidocaine with 1 : 100,000 epinephrine for the central incisor and first molar. However, neither anesthetic agent provided an hour of pulpal anesthesia.

Treatment of Bulimia with Desipramine: A Double-Blind Crossover Study

1988 ◽  
Vol 33 (2) ◽  
pp. 129-133 ◽  
Author(s):  
Jane Barlow ◽  
Jane Blouin ◽  
Arthur Blouin ◽  
Edgardo Perez
Keyword(s):  
Clinical Effect ◽  
Eating Attitudes ◽  
Tricyclic Antidepressant ◽  
Normal Weight ◽  
Crossover Design ◽  
Double Blind ◽  
Reverse Sequence ◽  
To Receive ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

The purpose of this study was to evaluate the effect of desipramine, a tricyclic antidepressant with relatively specific noradrenergic effects, on bulimic behaviour, eating attitudes, and mood. Using a double-blind crossover design, 47 normal weight bulimics were randomly assigned to receive either desipramine (150 mg/day)for six weeks, no drug for three weeks, followed by placebo for six weeks, or the reverse sequence. At weeks 0, 2, 4, 6, 9, 11, 13, and 15, each subject was assessed using the EDI, SCL-90, POMS and binge records. Plasma desipramine levels were obtained at weeks 4 and 13. Twenty-four subjects completed the entire fifteen week protocol, while 23 dropped out. Desipramine was significantly more effective than placebo in reducing the frequency of weekly hinging, weekly vomiting, and the fatigue scale of the POMS. No significant effect of the drug was obtained on the EDI or the SCL-90. The clinical effect was modest. Desipramine's antibulimic effects were not associated with an alleviation of depressive symptoms.

scholarly journals A Prospective, Randomized, Double-Blind Comparison of 2% Lidocaine With 1 : 100,000 Epinephrine, 4% Prilocaine With 1 : 200,000 Epinephrine, and 4% Prilocaine for Maxillary Infiltrations

2010 ◽  
Vol 57 (2) ◽  
pp. 45-51 ◽  
Author(s):  
Steven Katz ◽  
Melissa Drum ◽  
Al Reader ◽  
John Nusstein ◽  
Mike Beck
Keyword(s):  
Crossover Study ◽  
Lateral Incisor ◽  
Anesthetic Agent ◽  
Double Blind ◽  
Maxillary Lateral Incisor ◽  
Blind Comparison ◽  
Blind Manner ◽  
Pulpal Anesthesia ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Abstract The purpose of this prospective, randomized, double-blind crossover study was to evaluate the anesthetic efficacy of 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine in maxillary lateral incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary lateral incisor and first molar infiltrations of 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine, 1.8 mL of 4% prilocaine with 1 : 200,000 epinephrine, and 1.8 mL of 4% prilocaine, at 3 separate appointments spaced at least 1 week apart. The teeth were pulp-tested in 3-minute cycles for a total of 60 minutes. Anesthetic success (ie, obtaining 2 consecutive 80 readings with the electric pulp tester) and onset of pulpal anesthesia were not significantly different between 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine for the lateral incisor and first molar. For both lateral incisor and first molar, 4% prilocaine with 1 : 200,000 epinephrine and 2% lidocaine with 1 : 100,000 epinephrine were equivalent for incidence of pulpal anesthesia. However, neither anesthetic agent provided an hour of pulpal anesthesia. For both lateral incisor and first molar, 4% prilocaine provided a significantly shorter duration of pulpal anesthesia compared with 2% lidocaine with 1 : 100,000 epinephrine and 4% prilocaine with 1 : 200,000 epinephrine.

Effect of Flumazenil on Ventilatory Drive during Sedation with Midazolam and Alfentanil

1996 ◽  
Vol 85 (4) ◽  
pp. 713-720 ◽  
Author(s):  
Jeffrey B. Gross ◽  
Robert T. Blouin ◽  
Shaul Zandsberg ◽  
Pattilyn F. Conard ◽  
Jurgen Haussler
Keyword(s):  
Carbon Dioxide ◽  
Respiratory Depression ◽  
Minute Ventilation ◽  
Study Drug ◽  
Double Blind ◽  
Ventilatory Responses ◽  
Ventilatory Drive ◽  
To Receive ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Background Patients who receive a combination of a benzodiazepine and an opioid for conscious sedation are at risk for developing respiratory depression. While flumazenil effectively antagonizes the respiratory depression associated with a benzodiazepine alone, its efficacy in the presence of both a benzodiazepine and an opioid has not been established. This study was designed to determine whether flumazenil can reverse benzodiazepine-induced depression of ventilatory drive in the presence of an opioid. Methods Twelve healthy volunteers completed this randomized, double-blind, crossover study. Ventilatory responses to carbon dioxide and to isocapnic hypoxia were determined during four treatment phases: (1) baseline, (2) alfentanil infusion; (3) combined midazolam and alfentanil infusions, and (4) combined alfentanil, midazolam, and "study drug" (consisting of either flumazenil or flumazenil vehicle) infusions. Subjects returned 2-6 weeks later to receive the alternate study drug. Results Alfentanil decreased the slope of the carbon dioxide response curve from 2.14 +/- 0.40 to 1.43 +/- 0.19 l.min-1.mmHg-1 (x +/- SE, P &lt; 0.05), and decreased the minute ventilation at P(ET)CO2 = 50 mmHg (VE50) from 19.7 +/- 1.2 to 14.8 +/- 0.9l.min-1 (P &lt; 0.05). Midazolam further reduced these variables to 0.87 +/- 0.17 l.min-1.mmHg-1 (P &lt; 0.05) and 11.7 +/- 0.8 l.min-1 (P &lt; 0.05), respectively. With addition of flumazenil, slope and VE50 increased to 1.47 +/- 0.37 l.min-1.mmHg-1 (P &lt; 0.05) and 16.4 +/- 2.0l.min-1 (P &lt; 0.05); after placebo, the respective values of 1.02 +/- 0.19 l.min-1.mmHg-1 and 12.5 +/- 1.2 l.min-1 did not differe significantly from their values during combined alfentanil and midazolam administration. The effect of flumazenil differed significantly from that of placebo (P &lt; 0.05). Both the slope and the displacement of the hypoxic ventilatory response, measured at P(ET)CO2 = 46 +/- 1 mmHG, were affected similarly, with flumazenil showing a significant improvement compared to placebo. Conclusions Flumazenil effectively reverses the benzodiazepine component of ventilatory depression during combined administration of a benzodiazepine and an opioid.

A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis.

1994 ◽  
Vol 12 (3) ◽  
pp. 596-600 ◽  
Author(s):  
P J Hesketh ◽  
W H Harvey ◽  
W G Harker ◽  
T M Beck ◽  
T Ryan ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Dose ◽  
Double Blind ◽  
Treatment Groups ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Abdominal Colic ◽  
Safety Parameters ◽  
Blind Comparison ◽  
To Receive

PURPOSE This study compares the efficacy and safety of ondansetron alone with that of ondansetron plus dexamethasone in the prevention of emesis induced by high-dose cisplatin (> or = 100 mg/m2). PATIENTS AND METHODS This multicenter study used a randomized, double-blind, parallel-group design. Chemotherapy-naive patients were randomized to receive intravenous (IV) ondansetron (Zofran, Cerenex Pharmaceuticals, Research Triangle Park, NC) 0.15 mg/kg for three doses every 4 hours beginning 30 minutes before cisplatin administration either alone or in combination with dexamethasone 20 mg administered 45 minutes before cisplatin. Cisplatin (> or = 100 mg/m2) was administered as a single infusion (< or = 3 hours). Patients were monitored for emetic episodes (EEs), adverse events, and laboratory safety parameters for 24 hours after cisplatin administration. RESULTS A total of 275 patients were enrolled. Of these, 245 were assessable for efficacy. Patients who received ondansetron plus dexamethasone had a higher complete antiemetic response rate (61% v 46%, P = .02) and less nausea (posttreatment visual analog scale mean 18.2 v 32.8, P < .001) than did those who received ondansetron alone. The time to the first EE was longer for patients in the group that received ondansetron plus dexamethasone (P = .005). Headache (12%), diarrhea (2%), and abdominal colic (1%) were the most common antiemetic-related adverse events reported. The incidence of adverse events was similar between the treatment groups. CONCLUSION IV ondansetron in combination with dexamethasone is safe and more effective than ondansetron alone in the prevention of emesis induced by high-dose cisplatin.

Pharmacokinetics and Tolerability of Factor XIII Concentrates Prepared from Human Placenta or Plasma: a Crossover Randomised Study

1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  
Keyword(s):  
Factor Xiii ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomised Study ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study ◽  
Fxiii Activity ◽  
Observation Period

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

Inhibition of Spontaneous Platelet Aggregation by Sulfinpyrazone

1979 ◽  
Vol 42 (02) ◽  
pp. 621-625 ◽  
Author(s):  
G G Nenci ◽  
G Agnelli ◽  
M Berrettini ◽  
P Parise ◽  
E Ballatori
Keyword(s):  
Platelet Aggregation ◽  
Crossover Study ◽  
Double Blind ◽  
Platelet Aggregability ◽  
Initiation Of Therapy ◽  
Spontaneous Platelet Aggregation ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

SummaryIn a randomized double-blind crossover study in 16 patients with enhanced in vitro spontaneous platelet aggregation, sulfinpyrazone proved to be effective in normalizing platelet aggregability within 4 days after initiation of therapy.

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