Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Proportion of patients with significant pain
研究概览
简要总结
Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a LP.
详细描述
Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has only been investigated in a single-centre study.
Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.
Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding).
The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.
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, Outcomes Assessor)
盲法说明
double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used
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
- •Patients coming in the neurology department for a lumbar puncture
- •at least 18
- •no previous use of nitrous oxide
排除标准
- •contra-indication to nitrous oxide use
- •Body Mass Index>35
- •Mini Mental State Examination <24/30
- •Temperature >38°C
- •Confusion
- •Patient unable to communicate verbaly
研究组 & 干预措施
Placebo
will inhale medical air (22% O2 - 78% N2)
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of patients with significant pain
时间窗: 2-3 minutes after the end of gaz inhalation
maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
次要结局
- Proportion of patients with significant anxiety(2-3 minutes after the end of gaz inhalation)
- Analgesic efficacy measured with pain as a continuous variable(2-3 minutes after the end of gaz inhalation.)
- Anxiolytic efficacy measured with anxiety as a continuous variable(2-3 minutes after the end of gaz inhalation)
- Pain during the procedure evaluated one hour after the end of the lumbar puncture(1 hour after the end of gaz inhalation)
- Anxiety during the procedure evaluated one hour after the end of the lumbar puncture(1 hour after the end of gaz inhalation)
- Side effects(from the beginning of gaz inhalation to 24 hours later)
- Impact of age on side effects(during the procedure and the 24 hours after)
- Induced cost(at day 1)