2023-506252-24-00已完成4 期
Perioperative methadone compared to placebo in elderly hip fracture patients – a randomized controlled trial. Phase two of the MetaHip trial
Sygehus Soenderjylland Soenderborg1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年10月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Daily consumption of opioids
研究概览
简要总结
To investigate the analgesic effect of a single dose of methadone compared with a placebo in acute hip fracture surgery.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with an acute hip fracture (incurred <24 hours ago) on x-rays in the emergency department. This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- •Age ≥ 60 years.
排除标准
- •Multiple fractures.
- •Previous allergic reactions or hypersensitivity towards methadone hydrochloride or sodium chloride.
- •Health conditions preventing treatment: • Chronic obstructive pulmonary disease with either past exacerbations or daily symptoms • History of acute asthma attacks • History of drug-induced eczema • Pulmonary hypertension • Raised intracranial pressure or recent head injury • Pheochromocytoma • History of paralytic ileus • QT-interval prolongation on electrocardiogram (ECG) • Myasthenia gravis • Known liver disorder • Hypotension (systolic blood pressure <100 mmHg at admission).
- •Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products.
- •Concurrent administration of benzodiazepines.
- •Impaired cognitive function e.g. dementia. Patients must be able to give informed consent and be able to ask for supplementary analgesics if needed.
- •Current opioid addiction or intravenous addiction.
- •Multi-trauma patient
结局指标
主要结局
Daily consumption of opioids
Daily consumption of opioids
次要结局
- Pain
- Standing up
- Mobility
- Nausea or vomiting
- Time to discharge
- Need for an antidote
- Delirium
- Constipation
研究者
Department of orthopedics
Scientific
Sygehus Soenderjylland Soenderborg
研究点 (1)
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