Acute Severe Traumatic Pain in the ED : Can we Improve Time to Pain-relief With a Single Dose of Intranasal Sufentanil Given at Triage ? A Randomized Double-blinded Placebo Controlled Study (InSPEED Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Pain relief assessment
研究概览
简要总结
Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients.
This randomized double-blind placebo-controlled study will focus on severe traumatic pain experienced by adults admitted in our ED.
We hypothesized that, in addition to traditional morphine titration, a single dose of IN sufentanil given at triage would significantly increase the proportion of patients relieved 30 minutes after their ED admission.
Time to discharge, proportion of side effects and satisfaction rates will also be recorded.
详细描述
Time to pain-relief can vary widely in the Emergency Department (ED), depending on various factors such as ED overcrowding or inadequate training in pain management.
As intravenous (IV) opioid administration is world-wide recommended for severe pain treatment, delays from triage to room admission and to first IV injection directly influence this time to pain-relief. Moreover, it is proven that an incorrect adherence to morphine titration protocol can participate in ED oligoanalgesia.
Although ED experience in intranasal (IN) opioid administration is still lacking, this simple and non-invasive way of treating pain seems safe and promising. Opioid pharmacokinetic by IN route indeed is interesting for ED practitioners : while assuring a timely analgesia, the lower Cmax and delayed Tmax by IN route can theoretically limit the risk of respiratory depression, in comparison with IV route.
We propose a randomized double-blind placebo-controlled study on a convenience sample of adult patients admitted in our ED (annual census of 80000 attendances) for an isolated limb injury, and experiencing a severe pain (score > 5/10 on numerical pain scale).
For primary outcome, we will compare the proportion of patients relieved (score < 4/10) 30 minutes after admission, depending on the administration (or not) of a single intranasal dose of sufentanil (0,4 mcg/kg) given by the triage nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single traumatic limb injury.
- •Severe pain (score > 5/10 on numerical pain scale)
- •Age ≥ 18 years and < 75 years
排除标准
- •Abdominal, thoracic, vertebral or cranial injury associated
- •Hemodynamic instability (systolic blood pressure < 100 mmHg and/or blood pulse > 110 / min)
- •Oxygen saturation < 96% on room air
- •Chronic respiratory, renal or cardiac failure
- •Impaired mental status (Glasgow Coma Scale < 15)
研究组 & 干预措施
Intranasal placebo
Patients receiving intranasal placebo at ED admission
干预措施: Placebo (Drug)
Intranasal sufentanil
Patients receiving intranasal sufentanil at ED admission
干预措施: Sufentanil (Drug)
结局指标
主要结局
Pain relief assessment
时间窗: 30 minutes after ED admission
Proportion of patients pain-relieved (score \< 4/10 on numerical pain scale) at T30 (30 minutes after their admission)
次要结局
- Pain assessment(30 minutes after ED admission)
- opioids-related side-effects(2h after last opioid injection.)
- time to pain relief treatment(30 minutes after ED admission)
- Patient satisfaction(at discharge)
- ED length of stay(8 h after ED admission)
- Nurse satisfaction(at discharge)
- Delay from first opioid injection to pain-relief(30 minutes)