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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
inhale medical air (22% O2 - 78% N2)
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
RECRUITINGMaximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
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?"
Time frame: 2-3 minutes after the end of gas inhalation
Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale
Proportion of patients with significant anxiety
Time frame: 2-3 minutes after the end of gas inhalation
Side effects
Every side effect reported by the patients attributable to gas inhalation during the procedure up to emergency service discharge. Presence, intensity and reversibility will be recorded
Time frame: From the beginning of gas inhalation to a minimum of 2 hours later
Spinal puncture duration
Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal).
Time frame: 2-3 minutes after the end of lumbar puncture
Number of attempts before successful LP
Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam.
Time frame: 2-3 minutes after the end of lumbar puncture
Patient Satisfaction
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overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions
Time frame: 2-3 minutes after the end of gas inhalation
Blinding quality
Assessment of blinding in clinical trials (according to Bang et al. 2004)
Time frame: 2-3 minutes after the end of gas inhalation
Induced cost
supplementary cost induced by the use of nitrous oxide inhalation for a total of 88 patients throughout the study (gas and consumables such as masks and pipes)
Time frame: through study completion, an average 4 months