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临床试验/NCT00475306
NCT00475306已完成4 期

A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
289
试验地点
1
主要终点
Nausea Scale

研究概览

简要总结

Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

详细描述

The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.

In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary or secondary complaints of nausea/vomiting
  • age 21-65

排除标准

  • pregnancy
  • use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
  • previous adverse reaction to study medications
  • use of opioid medications prior to study start time within that ED visit

研究组 & 干预措施

Metoclopramide 20+placebo

Active Comparator

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

干预措施: Metoclopramide 20 mg (Drug)

Metoclopramide 20+diphenhydramine

Active Comparator

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

干预措施: Diphenhydramine 25 mg (Drug)

Metoclopramide 20+diphenhydramine

Active Comparator

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

干预措施: Metoclopramide 20 mg (Drug)

Metoclopramide 20+placebo

Active Comparator

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

干预措施: Placebo (Drug)

Metoclopramide 10 + placebo

Active Comparator

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

干预措施: metoclopramide 10 mg (Drug)

Metoclopramide 10 + placebo

Active Comparator

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

干预措施: Placebo (Drug)

Metoclopramide 10+diphenhydramine

Active Comparator

Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes

干预措施: metoclopramide 10 mg (Drug)

Metoclopramide 10+diphenhydramine

Active Comparator

Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes

干预措施: Diphenhydramine 25 mg (Drug)

结局指标

主要结局

Nausea Scale

时间窗: 60 minutes

Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable

次要结局

  • Number of Participants With Akathisia(60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Friedman

Associate professor

Montefiore Medical Center

研究点 (1)

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