Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
研究概览
简要总结
Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.
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 scheduled setting.Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.
Patients with urgent 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. 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
double blinding, gas bottles are in undistinguishable boxes, and each gas mask will be filled with odorous ink masking the sweet flavour of N2O. Neither the patient nor the person doing the LP and/or 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
- •Adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose
- •at least 18
- •affiliated to the French state healthcare insurance system
- •able to give consent to participation
排除标准
- •Previous use of nitrous oxide (medical or recreational)
- •Contra-indication to nitrous oxide use
- •Face mask phobia
- •Stage II obesity (BMI > 35)
- •Hemodynamic instability and/or any case when coagulation results cannot be waited
- •Cognitive condition defined by a previous Mini Mental State Examination < 24/30
- •Confusion or any consciousness disorder that might interfere with judgment or consent
- •Patient unable to communicate verbally
- •Patient placed under a legal protection measure (tutorship, curatorship or a mandate)
- •Any medical condition that might contra-indicate medical research, in physician's opinion
研究组 & 干预措施
Placebo
will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)
干预措施: Placebo (Other)
结局指标
主要结局
Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
时间窗: 2-3 minutes after the end of gas inhalation
Maximal level of pain during lumbar puncture. The patient will be asked to circle the digit that best describes the maximal level of pain felt during the procedure. If the patient is too painful and/or is incapacitated, the collection notebook will be fulfilled by the care provider after asking the following question: "On a scale of 0 to 10, 0 being the absence of pain and 10 the maximal pain you can imagine, what is the digit best describing the maximal pain you felt during the procedure?"
次要结局
- Side effects(From the beginning of gas inhalation to a minimum of 2 hours later)
- Patient Satisfaction(2-3 minutes after the end of gas inhalation)
- Number of attempts before successful LP(2-3 minutes after the end of lumbar puncture)
- Spinal puncture duration(2-3 minutes after the end of lumbar puncture)
- Induced cost(through study completion, an average 4 months)
- Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale(2-3 minutes after the end of gas inhalation)
- Blinding quality(2-3 minutes after the end of gas inhalation)