Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
研究概览
简要总结
Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain
详细描述
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 108 patients assigned in two parallel groups, defined by a randomization scheme. Four sites will participate to the research. Eligible patients with a numeric rating scale (NRS) score higher than 6/10 are randomly allocated to receive either MEOPA, or medical air. Neither the investigator nor the nurse knows the treatment. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, and oxygen saturation by pulse oximetry (SpO2) and adverse events collection.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years old and over
- •Severe acute pain (NRS score greater than 6)
排除标准
- •Contraindication of premixed 50% nitrous oxide and oxygen
研究组 & 干预措施
Premixed 50% nitrous oxide and oxygen
The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. Premixed 50% nitrous oxide and oxygen is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10.
干预措施: Premixed 50% nitrous oxide and oxygen (Drug)
Medical air
The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. The medical air is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10.
干预措施: Medical Air (Drug)
结局指标
主要结局
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
时间窗: 15 minutes after randomisation
次要结局
- Duration of analgesia.(From randomization until 48 hours)
- time to analgesia(From randomization until 48 hours)
- adverse events(From the randomization until 48 hours after randomization)