EUCTR2011-000194-31-GB进行中(未招募)1 期
An open randomised trial of patient controlled analgesia (PCA) versus routine care in the Emergency Department - PAin SoluTions In the Emergency Setting (PASTIES)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult patients aged between 18 and 75 years of age inclusive. •Traumatic injuries or non-traumatic abdominal pain. •In severe pain on arrival in the Emergency Department. •Admission to hospital is intended at the time of enrolment. •Provision of informed consent to participate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients over 75 years •Patients with a reduced conscious level •Inability to operate a PCA device. •Patients who cannot understand the study information (e.g. due to pre-existing dementia, learning difficulties, or intoxication). •Patients with chronic pain. •Patients who are opioid tolerant. •Patients with active opioid addiction. •Patients with a history of renal failure. •Allergy or other contraindication to morphine. •Hypotension (systolic blood pressure <90mmHg). •Patients in police custody, or prisoners. •Inability to gain IV access. •Patients who are likely to be definitively treated in the ED and discharged. •Patients who are pregnant or breast-feeding. •Open fractures (excluded because this group of patients will undergo surgery within six hours of injury according to national standards). •Patients on other predetermined analgesia pathway (e.g. regional anaesthesia). •Previous participation in this study. •Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP).
研究者
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Patient controlled analgesia (PCA) versus routine care in the Emergency DepartmentTopic: Injuries and EmergenciesSubtopic: Injuries and Emergencies (all Subtopics)Disease: Injuries and EmergenciesInjury, Occupational Diseases, PoisoningInjuries and emergenciesISRCTN25343280Plymouth Hospitals NHS Trust (UK)400
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