Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Maximal pain level during the procedure
研究概览
简要总结
This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.
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 never been investigated properly.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients coming in the neurology department for a scheduled lumbar puncture
- •18 to 60 years.
- •no previous use of nitrous oxide
排除标准
- •contra-indication to nitrous oxide use
- •Body Mass Index>35
- •Mini Mental State Examination <26/30
- •Temperature >38°C
- •Confusion
- •Patient unable to communicate verbaly
结局指标
主要结局
Maximal pain level during the procedure
时间窗: at day 1
次要结局
- Maximal anxiety level during the procedure(at day 1)
- Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)(at day 1)
- Proportion of patients presenting side effects(at day 1)
- Total duration of the lumbar puncture(at day 1)
- Proportion of patients that would accept another lumbar puncture in the same conditions(at day 1)