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To compare the effects of midazolam, which is a fast and short-acting benzodiazepine, and diphenhydramine, which is a widely used anticholinergic agent, in clinical practice for the treatment of metoclopramide-induced akathisia.
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Of 152 patients screened, 97 were eligible and 77 were randomized. The mean change in numeric rating scale scores at 1 hour was 5.5 and 5.2 in subjects receiving prochlorperazine and metoclopramide, respectively (difference=0.3; 95% confidence interval [CI] -1.0 to 1.6). Findings were similar at 2 hours and 24 hours. Forty-six percent (18/39) of prochlorperazine and 32% (12/38) of metoclopramide subjects reported adverse events (difference=15%; 95% CI -6% to 36%). Seventy-seven percent (26/34) of prochlorperazine and 73% (27/37) of metoclopramide subjects wanted to receive the same medication in future ED visits (difference=4%; 95% CI -16% to 24%).
Combined metoclopramide-continuous low-dose erythromycin was found to be the best protocol in the current study to increase GER in ventilated patients. It should be tested as a first-line prokinetic therapy in ventilated patients with poor gastric emptying in further randomized controlled studies. The breath-test device presented in this study can be a user-friendly and practical method to monitor GER, enabling individual tailoring of prokinetic therapy. Further studies to explore its utility are warranted.
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Five patients with tardive dyskinesia (average age, 64 years) were treated with a central dopamine blocking agent, metoclopramide hydrochloride. The duration of symptoms ranged from four to 30 months. A pretreatment disability score was graded (0 to 4) for buccolingual, extremity, and truncal movements and for duration of tongue protrusion. A 59% improvement was achieved in total disability scores. Tongue protrusion demonstrated the most noticeable improvement. The average daily dosage ranged from a minimum of 20 mg to a maximum of 80 mg given in divided doses. Duration of follow-up ranged from three to eight months. Preliminary data suggest that metoclopramide may be effective in the treatment of tardive dyskinesia.
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Phase II studies on ifosfamide and mesna in pancreatic cancer have mostly been inconclusive. In all of these studies ifosfamide was administered as an i.v. bolus or by short infusions. Since dose fractionation of ifosfamide over several days increases its therapeutic index, we chose to maximize the dose fractioning by selecting a continuous-infusion schedule (1.75 g/m2 on days 1-5 every 21-28 days, with mesna 60%-100% of the ifosfamide dose up to 12 h after ifosfamide). Since 1987 29 patients (performance status less than or equal to 2) with advanced inoperable adenocarcinoma of the pancreas were studied (8 women and 21 men; median age 58 years: 36-73 years). A total of 25 patients are evaluable for response (1 ineligible; 3 inevaluable: 2 early deaths due to disseminated intravascular coagulation, 1 refusal). One female patient with a complete response on computed tomography scan (after five cycles) but residual liver metastases on surgical exploration survived for 473 days. Three male patients with partial response survived for 205, 335 and 355 days. Six more patients with minor response (3) or no change (3) but significant decrease of tumour marker CA 19-9 had a median survival of 213 days (106-243). Responders seemed to benefit in terms of pain relief and general well-being. The median overall survival of all patients was 148 days (21-473). Haematotoxicity was rarely dose-limiting [median nadirs: white blood cells = 2.1 x 10(9)/l (0.45-6.4), Hb = 10.7 g/dl (7.5-13), platelets = 137 x 10(9)/l (21-411)]. Nausea and vomiting were mild with prophylactic oral metoclopramide. No central nervous system toxicity or urotoxicity was observed. Alopecia was seen in all patients who had received at least two cycles. Continuous infusion of ifosfamide was generally well tolerated and useful for palliation in 10 of 25 patients. A higher dose intensity is recommended.
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The emesis was induced by raw pinellia in minks (P < 0.01); ginger-processed Rhizoma pinelliae, metoclopramide and ondansetron significantly inhibit the emesis induced by cisplatin and apomorphine (P < 0.05).
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In 1976, 310 patients attended the Princess Margaret Clinic for treatment of an acute headache. 90% were either symptom-free or had only slight residual headache after 4 h. The treatment given was metaclopramide and an effervescent analgesic. 69% of patients had some form of sedation and 10% ergotamine tartrate. Those patients who had treatment between 6 and 12 h following the onset of an attack had significantly fewer attacks in the next 7 days. Patients who slept during an attack, with a sedative where indicated, recovered more quickly than those who did not sleep. The depth of sleep did not affect the rate of recovery. A higher percentage of patients with migraine compared with those with tension headache were either symptom-free or had only slight residual headache on leaving.
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Although global health status, co-morbidities, and time-invariant factors were adjusted for, residual confounding cannot be ruled out.
4 cases of extrapyramidal disturbances, observed in children with Metoclopramid-medication, are reported. These side-effects may occur already at normal therapeutic dosage, especially in the young patient. The side-effects are reversible, and respond easily to i.v. injection or peroral application of anti-parkinsonian drugs, less severe cases may subside by withdrawal of the drug. The therapeutic use in the pediatric field must be strictly indicated because of the special disposition of children to the side-effects described above.
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Prospective, randomized, placebo-controlled, double-blinded study.
Oesophageal, lower oesophageal sphincter and gastric fundal pressures were measured with a triple lumen, open tip-infused catheter in dogs before and after intravenous injection of metoclopramide. The mean basal value of the lower oesophageal sphincter pressure was 5.3+/-2.7 mmHg. Metoclopramide injection caused a significant increase in this pressure. The effect of metoclopramide started immediately and disappeared about one hour after intravenous injection.
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To report a case of possible cisplatin-associated hepatotoxicity.
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Maropitant (Cerenia; a novel, selective neurokinin(1) receptor antagonist), chlorpromazine, metoclopramide and ondansetron were compared in two randomized, placebo-controlled studies for efficacy in preventing emesis induced by emetogens acting centrally (apomorphine; Study 1) or peripherally (syrup of ipecac; Study 2) in dogs. In each study, ten male and ten female beagles were treated in a five-treatment, five-period crossover design. The five treatments were 0.9% saline (0.1 mL/kg), maropitant (1 mg/kg), metoclopramide (0.5 mg/kg), or chlorpromazine (0.5 mg/kg) all administered subcutaneously, or ondansetron (0.5 mg/kg) administered intravenously. One hour posttreatment dogs were challenged with apomorphine at 0.1 mg/kg intravenously (Study 1) or syrup of ipecac at 0.5 mL/kg orally (Study 2). Following emetogen challenge, dogs were observed for 30 min (Study 1) or 1 h (Study 2) for emesis. No clinical signs, other than those related to emesis, were observed. Efficacy of maropitant in preventing emesis induced centrally by apomorphine was not different (P > 0.05) from metoclopramide or chlorpromazine but was superior (P < 0.0001) to ondansetron. Efficacy of maropitant in preventing emesis induced by syrup of ipecac was not different (P > 0.05) from ondansetron but was superior (P = 0.0102) to metoclopramide or chlorpromazine. Maropitant was effective (P < 0.0001 relative to control) in preventing vomiting caused by stimulation of either central or peripheral emetic pathways, whereas the other drugs examined prevented vomiting caused by central (metoclopramide and chlorpromazine; P < 0.0001) or peripheral (ondansetron; P < 0.0001) stimulation but not both.
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Ondansetron is a serotonin antagonist that recently has been introduced as a preventive agent for chemotherapy-induced nausea and vomiting. The current study was performed to determine the degree of antiemetic control of ondansetron in combination with dexamethasone and lorazepam, and to compare this combination to the previously very effective regimen of lorazepam, dexamethasone, diphenhydramine, and continuous-infusion metoclopramide.
Solutions containing approximately 40 microg/ ml of fentanyl in combination with midazolam (approximately 600 microg/ml) and either metoclopramide (approximately 700 microg/l) or hyoscine (approximately 850 microg/ml) were prepared from commercial ampoules of the drugs. The solutions were stored, in triplicate, in the dark at 32 degrees C (to simulate usage conditions) for 10 days, and the concentration of each constituent drug was periodically determined using a stability-indicating high-performance liquid chromatography assay.
The effect of post-footshock injections of (+)-amphetamine, the selective D2-receptor agonist quinpirole (LY 171555), and the D2-receptor antagonist metoclopramide, into the nucleus accumbens, on the formation of the open field deficit, has been studied in rats. Microinjections of (+)-amphetamine (10 micrograms) stimulated rat locomotor activity tested 5 min later, while quinpirole (10 micrograms) significantly inhibited animal motility in the test. The open field behaviour was not changed 24 h after injection of either drug. Amphetamine applied immediately after inescapable footshock did not modify stress-induced locomotor depression, when the rats' behaviour was examined 24 h later. On the other hand, post-shock injections of quinpirole significantly attenuated the long-term effects of the stressor, in the open field. Metoclopramide (10 micrograms) inhibited rat locomotor activity 5 min, but not 24 h, after local injection. Administration of a solution containing both quinpirole (10 micrograms) and metoclopramide (1 microgram) decreased motor activity of unstressed rats to a smaller degree than did quinpirole (10 micrograms) alone. Post-footshock injection of metoclopramide did not affect stress-induced hypomotility. It is concluded that the present data support the hypothesis that local depletion of brain dopaminergic stores causes some behavioural effects of stressors.
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Total 116 patients referred for CE were randomized into two groups with 58 patients in each group. In treatment group patients received 10 mg metoclopramide intramuscular injection after swallowing the capsule and in control group no metoclopramide was administered. The gastric transit time, small bowel transit time, complete endoscopy rate were observed in both groups.
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The aim of this study is to evaluate the specificities of the irradiation of drugs in frozen aqueous solution. The structures of the degradation products were determined to gain insight into the radiolysis mechanisms occurring in frozen aqueous solutions. Metoclopramide hydrochloride and metoprolol tartrate were chosen as models. The frozen solutions were irradiated at dry ice temperature by high energy electrons at various doses. The drug purity (chemical potency) and the radiolysis products were quantified by HPLC-DAD. Characterization of the degradation products was performed by LC-APCI-MS-MS. The structures of the radiolysis products detected in irradiated frozen aqueous solutions were compared to those detected in solid-state and aqueous solutions (previous studies). For both metoclopramide and metoprolol, solute loss upon irradiation of frozen aqueous solutions was negligible. Five radiolysis products present in traces were identified in irradiated metoclopramide frozen solutions. Three of them were previously identified in solid-state irradiated metoclopramide crystals. The two others were formed following reactions with the hydroxyl radical (indirect effect). Only one fragmentation product was observed in irradiated metoprolol frozen solutions. For both drugs, radiosterilization of frozen solutions, even at high doses (25 kGy), was found to be possible.
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To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.
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A prospective, observational study.
Cisapride is a prokinetic agent believed to facilitate acetylcholine release from the myenteric plexus of the gut. The effect of cisapride on gastric emptying of solids was studied in 9 diabetic patients, all of whom had delayed gastric emptying of indigestible solids (gastroparesis). Six patients had chronic nausea and vomiting, and 3 had no symptoms. Cisapride (5 mg) was given intravenously 15 min before ingestion of a 400-kcal test meal and 10 indigestible solid radiopaque markers. On separate days and in random order each patient also received intravenous metoclopramide (10 mg) or placebo 15 min before ingestion of the meal and markers. Mean gastric emptying of radiopaque markers, assessed by serial radiographs of the gastric region, was accelerated by metoclopramide and cisapride, but the difference reached significance only with cisapride (p less than 0.05). There was considerable intersubject variability in gastric emptying responses to cisapride and metoclopramide. No side effects occurred with either drug. This study indicates that acute, intravenous administration of cisapride accelerates gastric emptying of indigestible solids in patients with diabetic gastroparesis.
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To avoid the accumulation of metoclopramide that occurs with repeated i.v. bolus doses, a new regimen for the administration of high-dose metoclopramide consisting of a loading dose followed by a continuous infusion was investigated to determine the pharmacokinetics and antiemetic efficacy of the drug when given in this manner. Nine patients with non-Hodgkin's lymphoma entered the study, of whom six completed the study, receiving each of three dosage schedules of metoclopramide during three consecutive courses of chemotherapy. In these six patients plasma metoclopramide half-life was 5.9 +/- 0.4 h (mean +/- s.e. mean) and plasma clearance was 25.4 +/- 4.8 l/h (mean +/- s.e. mean). Neither half-life nor clearance were dose-related. Steady-state was achieved during 9/18 infusions. Nausea and vomiting were completely controlled in 13/24 treatment courses (57%) and adverse effects were minimal. We conclude that steady-state plasma concentrations of metoclopramide can be achieved using a weight-related infusion regimen, though the optimum plasma concentration remains to be determined.
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The aim of this survey was to examine the incidence of duodenogastric reflux in patients with abdominal complaints and the relations between the nature and extent of reflux abdominal complaints, the use of drugs, smoking, the drinking of coffee and alcohol and histological changes in the gastric mucosa. A comparison was also made between gastric ulcer patients and patients with upper abdominal complaints with respect to the nature and extent of reflux. The patients examined included 107 with abdominal complaints and 33 with a gastric ulcer. Gastroscopy was performed, followed by determination of intragastric bile acids and lysolecithin and a duodenogastric isotope reflux examination using technetium-99m-diethyliminodiacetic acid (Tc-99m HIDA). Intragastric bile acid concentrations in the patients with upper abdominal complaints were in the range 7-21,458 mumol/l (mean 964 +/- 2342 mumol/l) and lysolecithin concentrations in the range 0-1992 mumol/l (mean 70 +/- 273 mumol/l). Isotope reflux was observed in 48% of the patients, the reflux index varying in the range 0-70% (mean 4 +/- 9%). The patients suffered more frequently from nausea, epigastric fullness and flatulence with increasing reflux, as assessed by the various methods used here, but only the increase in epigastric fullness symptoms with rising intragastric bile acid concentrations was statistically significant (p less than 0.05). Similarly the various measures of reflux were higher in those patients taking anticholinergic, psychotherapeutic or cardiovascular drugs, antacids or metoclopramide than in the patients not taking the respective drugs, although the only statistically significant increases were in intragastric bile acids among the users of antacids and metoclopramide (p less than 0.01 and p less than 0.05, respectively) and the increase in lysolecithin concentrations among those taking metoclopramide (p less than 0.05). Those abstaining from alcohol had an intragastric bile acid concentration over 1000 mumol/l significantly more often than those who drank alcohol (p less than 0.05), but smoking and the drinking of coffee showed no significant correlation with duodenogastric reflux. The body gastritis score increased significantly with the extent of isotope reflux and the concentrations of intragastric bile acids (p less than 0.05 and p less than 0.01, respectively), and the latter also showed a significant correlation with serum gastrin (p less than 0.05). No significant relationship could be detected between intragastric lysolecithin concentrations and the gastritis score.(ABSTRACT TRUNCATED AT 400 WORDS)
The postoperative pain scores were significantly lower in the first half-hour period in the LB group than in the NS group (p<0.05). However, the incidence of right shoulder pain was not significantly different between the LB group (10%) and NS group (15%). The mean dose of meperidine consumption and the number of patients needing rescue meperidine were significantly lower in the LB group than in the NS group (p<0.05). Significantly lower vomiting incidence and increased patient satisfaction were determined in the LB group compared to the NS group (p<0.05).
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A prospective randomised controlled trial comparing rectal indomethacin with placebo was performed in children. Thirty children aged seven years and over undergoing open appendicectomy were given suppositories of either indomethacin 2 mg/kg or placebo. Suppositories were given at the conclusion of surgery and again 12 and 24 hours later. All children were given morphine by a patient-controlled analgesia pump. After 36 hours, children given indomethacin had used 0.51 (SD 0.34) mg/kg, and children given placebo 0.91 (SD 0.46) mg/kg (P < 0.02). Pain scores measured with a visual analogue scale, sedation scores and the incidence of vomiting were similar in both groups. Children given indomethacin suppositories used 44% less morphine than children given placebo, and at the same time obtained similar postoperative analgesia.
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A reversed-phase ion-pair HPLC method with ultraviolet detection has been developed for determination of metoclopramide (MCP) in bovine and swine muscle, liver, kidney, fat and intestine. MCP was extracted from samples with acetonitrile, and the extracts were cleaned up on an Oasis HLB cartridge (60 mg) after liquid-liquid extraction. The limit of detection of MCP was 0.002 microg/g and the limit of quantitation was 0.007 microg/g. Recoveries of MCP spiked at 0.03 ppm ranged from 74.1 to 93.3% for bovine tissues and from 86.1 to 92.7% for swine tissues. The present method was used for the analysis of bovine and swine tissues 1 day after withdrawal following drug administration. The MCP concentrations in all tissues were lower than the Japanese provisional MRLs.
Three cases of drug-induced akathisia during palliative care in terminal cancer patients were reported. Antiemetics (metoclopramide and prochlorperazine) possessing a central antidopaminergic effect were suspected to have caused the akathisia. Akathisia, as well as extrapyramidal symptoms, is a common and unpleasant complex neurobehavioral adverse effect of conventional antipsychotic drugs. But it is not widely recognized by general clinicians. This syndrome consists of subjective (feeling of inner restlessness, mental unease, or dysphoria and the urge to move) and objective components (restless movement, including rocking on one's feet, walking in position shuffling and tramping the legs,and crossing and uncrossing one's legs while sitting). In severe cases, patients constantly pace up and down in an attempt to relieve the sense of unrest. While the pathophysiology of drug-induced akathisia remains unknown, antagonism of the mesocortical and mesolimbic dopaminergic pathways is a plausible if not completely satisfactory hypothesis. The notion that dopaminergic blockade underlies the emergence of akathisia is supported by the PET studies. Since akathisia is a drug-induced adverse effect, optimal management involves its prevention rather than treatment. Drugs which have been found to have some efficacy in the treatment of akathisia are anticholinergics, beta-blockers, benzodiazepines and clonidine. Though a number of other treatments have been proposed, no trial-based evidences for treatment of akathisia have been available. It is important that akathisia is recognized and treated appropriately as an adverse reaction to drugs and a further increase in antipsychotic medication dosage may further exacerbate the condition.
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This guideline aims to provide an overview of the present knowledge on aspects of perioperative fasting with assessment of the quality of the evidence. A systematic search was conducted in electronic databases to identify trials published between 1950 and late 2009 concerned with preoperative fasting, early resumption of oral intake and the effects of oral carbohydrate mixtures on gastric emptying and postoperative recovery. One study on preoperative fasting which had not been included in previous reviews and a further 13 studies published since the most recent review were identified. The searches also identified 20 potentially relevant studies of oral carbohydrates and 53 on early resumption of oral intake. Publications were classified in terms of their evidence level, scientific validity and clinical relevance. The Scottish Intercollegiate Guidelines Network scoring system for assessing level of evidence and grade of recommendations was used. The key recommendations are that adults and children should be encouraged to drink clear fluids up to 2 h before elective surgery (including caesarean section) and all but one member of the guidelines group consider that tea or coffee with milk added (up to about one fifth of the total volume) are still clear fluids. Solid food should be prohibited for 6 h before elective surgery in adults and children, although patients should not have their operation cancelled or delayed just because they are chewing gum, sucking a boiled sweet or smoking immediately prior to induction of anaesthesia. These recommendations also apply to patients with obesity, gastro-oesophageal reflux and diabetes and pregnant women not in labour. There is insufficient evidence to recommend the routine use of antacids, metoclopramide or H2-receptor antagonists before elective surgery in non-obstetric patients, but an H2-receptor antagonist should be given before elective caesarean section, with an intravenous H2-receptor antagonist given prior to emergency caesarean section, supplemented with 30 ml of 0.3 mol l(-1) sodium citrate if general anaesthesia is planned. Infants should be fed before elective surgery. Breast milk is safe up to 4 h and other milks up to 6 h. Thereafter, clear fluids should be given as in adults. The guidelines also consider the safety and possible benefits of preoperative carbohydrates and offer advice on the postoperative resumption of oral intake.
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In order to evaluate the dopaminergic control of the lactotroph, we examined the plasma prolactin response to metoclopramide (a dopamine receptor blocker, 10 mg iv bolus) and to dopamine (1 microgram/Kg/min iv infusion for 120 min) in 52 hyperprolactinemic female patients and 19 healthy volunteer women. Three diagnostic categories were included: "idiopathic" hyperprolactinemia (21), microadenoma (24), and macroadenoma (7). Patients from all groups showed a marked blunting of the prolactin response to metoclopramide as compared to the prolactin rise in normal women (p less than 0.001). However, normal responses were observed in 8 patients with idiopathic hyperprolactinemia and in one patient with adenoma. The magnitude of the prolactin response to metoclopramide (percent of baseline level) correlated negatively with the level of basal prolactin in each group except for macroadenoma patients. Dopamine infusion significantly (p = 0.015) reduced the mean plasma prolactin levels in hyperprolactinemic patients and normal women. However, patients with idiopathic hyperprolactinemia were hyposensitive to dopamine (p less than 0.05). Furthermore, microadenoma patients were less responsive to dopamine suppression than were the patients with macroadenoma (p less than 0.05). The results indicate the presence of a relative resistance to dopamine in patients with idiopathic hyperprolactinemia and in patients with microadenoma. They also suggest that in these patients, the decrease in prolactin response to metoclopramide may be explained by the relative refractoriness to endogenous dopamine.
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All physician orders for metoclopramide tablets at a 500-bed hospital were monitored for a one-year period to determine whether the drug was being used exclusively for the one indication approved by the Food and Drug Administration, diabetic gastroparesis. Eighteen patients received a total of 20 courses of therapy with dosage schedules ranging from 5 mg tid to 10 mg qid. The drug was prescribed for a wide variety of indications, but no patient received it for the symptomatic treatment of diabetic gastroparesis. Extensive literature documentation was lacking for some of the uses, and the doses employed may have been insufficient in some cases. Uses of metoclopramide for both approved an nonapproved indications may increase as clinical studies further define its potential uses and physicians become more familiar with the drug.