Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse
研究概览
简要总结
Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil.
The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.
详细描述
Secondary objectives:
- To assess the rapidity of pain relief with intranasal sufentanil compared to intravenous morphine titration
- To compare the evolution over time of the pain with the old and new pain management protocol.
- To assess the safety of sufentanil and morphine titration
Conduct of research:
When a patient is admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale, the triage nurse or doctor checks the eligibility criteria. If eligible, the nurse or doctor ensures that the patient does not object to the reuse of their data for this research. An information letter is also given to the patient.
Pain will be measured by numerical rating scale at initial assessment by the triage nurse (baseline), at 15mins, 30mins, 60mins and 2hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to the Emergency Department of Mulhouse with a numerical pain rating scale > 3 ;
- •Patient who did not receive any analgesic except paracetamol in the 4 hours prior to admission ;
- •Initial pain assessment with the triage nurse ;
- •Patient does not object to the collection of data for the study.
排除标准
- •Patient admitted directly to the shock room ;
- •Initial pain assessment not performed in triage zone ;
- •Numerical Scale > 3 not corroborated by caregiver assessment: Algoplus <2
- •Onset of pain after triage nurse visit ;
- •Patient with drug intoxication, altered consciousness, alcohol or drug use.
结局指标
主要结局
Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse
时间窗: 30 minutes
Pain relief will be defined as numeric pain rating scale ≤ 3
次要结局
- Number of adverse events(2 hours)
- Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration(2 hours)