Prophylaxis Against Metoclopramide-Induced Akathisia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 主要终点
- akathisia and sedation scores
研究概览
简要总结
ABSTRACT
Study Objective:
To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide induced akathisia.
Methods:
This randomized, double-blind and controlled trial aimed to investigate co-administered midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia. Patients 18 through 65 years of age who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10 mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10 mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam, diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole procedure was observed, akathisia and sedation scores and vital changes were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study.
排除标准
- •Patients who had liver and renal insufficiency
- •Electrolyte imbalance
- •Acute respiratory symptoms
- •Chronic obstructive pulmonary disease
- •Blood pressure less than 90/60 mmHg
- •Uncooperative individuals
- •Pregnant or lactating
- •Pre-existing motor disorder
- •Restless legs syndrome-parkinson's disease
- •Organic brain disorder, (dementia etc.), epilepsy
- •Admitted to the ED due to acute psychiatric symptoms
- •Deprived mental status
- •Advanced hearing loss
- •Malnutrition
- •Acute asthma attack
- •Serious physical illness, especially glaucoma, prostatic hypertrophy, or cardiac disease
- •Had a contraindication to anticholinergic medications
- •Within 3 days of study entry patients who had taken an antiemetic antihistaminic, antipsychotic, antispasmodic, alpha-blocker, or Ca++2-channel blocker, or within 2 weeks of study entry patients who had taken an antidepressant, barbiturate, benzodiazepine, other sedative/hypnotic, opioid, lithium, or illicit sympathomimetic agent were excluded
研究组 & 干预措施
diphenhydramine
干预措施: midazolam (Drug)
saline
干预措施: midazolam (Drug)
结局指标
主要结局
akathisia and sedation scores
次要结局
未报告次要终点