A Non-randomised, Non-inferiority Comparative Study of Oral Actiskenan (Morphine Sulfate) Versus Intranasal Sufentanil in the Early Management of Severe Acute Pain in Emergency Departments.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Numerical Pain rating scale score 30 minutes after analgesic treatment is given
研究概览
简要总结
The main objective of this study is to evaluate whether the analgesic protocol combining oral Actiskenan is non-inferior to the protocol combining intranasal Sufentanil for treating severe pain in patients admitted to the emergency department.
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
详细描述
Secondary Objectives:
- To evaluate the non-inferiority of the analgesia protocol combining oral actiskenan compared with the protocol combining intranasal sufentanil, 60 minutes after the initial assessment.
- To describe the adverse effects associated with the analgesia protocols. These will be recorded following initiation of the analgesia protocol and will include nausea/vomiting, respiratory depression, dizziness, and impaired alertness.
Research conduct:
The study will not affect the care provided to patients admitted to the emergency departments of the participating centres. Each department will implement its own pain management protocol in accordance with usual care at that centre (i.e., analgesic protocol combining intranasal sufentanil and paracetamol at Emile Muller Hospital - Mulhouse, France; analgesic protocol combining oral actiskenan and paracetamol at Sélestat Hospital Center).
Digital pain assessments and monitoring of treatment-related adverse effects are already part of routine clinical practice for medical and nursing staff. To collect standardized data on pain assessment and treatment-related adverse effects, medical and nursing staff will complete a data collection form for each patient included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with severe acute pain of medical or traumatic origin at admission, with a score of 6 or higher on the numerical pain rating scale;
- •Aged 18 years or older;
- •No prior use of WHO step III analgesic before admission;
- •Hemodynamic, respiratory, and neurological stability;
- •Patient informed about the study and not opposed to participation.
- •Non-Inclusion Criteria:
- •Pain related to exacerbation of chronic and/or neuropathic pain;
- •Sickle cell crisis;
- •Patient with substance abuse.
排除标准
- 未提供
研究组 & 干预措施
Intranasal sufentanil
Patients admitted to the emergency department of Emile Muller Hospital in Mulhouse, France with a score of 6 or higher on the numerical pain rating scale.
干预措施: Intranasal Sufentanil (Drug)
Oral actiskenan
Patients admitted to the emergency departments of Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale.
干预措施: Oral Actiskenan (Drug)
结局指标
主要结局
Numerical Pain rating scale score 30 minutes after analgesic treatment is given
时间窗: 30 minutes after analgesic treatment is given
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
次要结局
- Numerical Pain rating scale score 60 minutes after analgesic treatment is given(60 minutes after analgesic treatment is given)